Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed

K171643 · Geistlich Pharma AG · NPL · Oct 30, 2017 · Dental

Device Facts

• Record ID: K171643
• Device Name: Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed
• Applicant: Geistlich Pharma AG
• Product Code: NPL · Dental
• Decision Date: Oct 30, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Geistlich Bio-Gide® Shape is indicated for: - augmentation around implants placed in immediate extraction sockets. - augmentation around implants placed in delayed extraction sockets. - localized ridge augmentation for later implantation. - alveolar ridge reconstruction for prosthetic treatment. - filling of bone defects after root resection, cystectomy, removal of retained teeth. - quided bone regeneration in dehiscence defects. Geistlich Bio-Gide® Compressed is indicated for: - auqmentation around implants placed in immediate extraction sockets. - augmentation around implants placed in delayed extraction sockets. - localized ridge augmentation for later implantation. - alveolar ridge reconstruction for prosthetic treatment. - filling of bone defects after root resection, cystectomy, removal of retained teeth. - guided bone regeneration in dehiscence defects. - guided tissue regeneration procedures in periodontal defects

Device Story

Geistlich Bio-Gide Shape and Compressed are resorbable bilayer collagen membranes used in dental surgery. The porous surface faces bone to facilitate osteoblast ingrowth; the dense surface faces soft tissue to prevent fibrous tissue infiltration. Devices are used by dentists/oral surgeons in clinical settings to support guided bone/tissue regeneration. They act as physical barriers during healing. Shape version is pre-cut for specific defect sizes; Compressed version includes a surface marking to ensure correct orientation. Both are derived from collagen, sterilized via gamma irradiation, and intended to improve bone/tissue healing outcomes in dental defects.

Clinical Evidence

Clinical performance established via reference devices (K960724, K042197). Studies included 75 patients for guided bone regeneration in implant placement and 15 patients for defect filling, showing effective bone regeneration with no serious adverse events. Additional literature on periodontal defects (recession, furcation, intrabony) involving over 200 patients demonstrated significant gains in clinical attachment level (CAL) and pocket depth reduction compared to controls (open-flap debridement). Safety profile is favorable; minor inflammation related to surgery was observed.

Technological Characteristics

Bilayer collagen membrane; 85-100% native collagen; porous/dense surfaces. Sterilized by gamma irradiation. Dimensions: Shape (14x24mm), Compressed (13x25mm, 20x30mm). Biocompatibility per ISO 10993; sterility per ISO 11137; viral clearance per ISO 22442-3. No software or electronic components.

Indications for Use

Indicated for patients requiring bone or tissue regeneration in dental procedures, including implant site augmentation (immediate/delayed extraction sockets), ridge augmentation/reconstruction, bone defect filling (post-resection/cystectomy/tooth removal), dehiscence defects, and periodontal defect regeneration.

Regulatory Classification

Identification

Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.

Special Controls

*Classification.* (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• Geistlich Bio-Gide® Perio (K112575)

Reference Devices

• Geistlich Bio-Gide® (K960724)
• Geistlich Bio-Gide® (K042197)
• Geistlich Bio-Gide® (K112572)

Submission Summary (Full Text)

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October 30, 2017

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Geistlich Pharma AG % Janice Hogan Regulatory Counsel Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103

Re: K171643

Trade/Device Name: Geistlich Bio-Gide Shape. Geistlich Bio-Gide Compressed Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPL Dated: September 25, 2017 Received: September 25, 2017

Dear Janice Hogan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Mary S. Runner -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page

510(k) Number (if known)

K171643

Device Name

#### Geistlich Bio-Gide® Shape

Indications for Use (Describe)

Geistlich Bio-Gide® Shape is indicated for:

- augmentation around implants placed in immediate extraction sockets.
- augmentation around implants placed in delayed extraction sockets.
- localized ridge augmentation for later implantation.
- alveolar ridge reconstruction for prosthetic treatment.
- filling of bone defects after root resection, cystectomy, removal of retained teeth.
- quided bone regeneration in dehiscence defects.

Type of Use (Select one or both, as applicable)

ا Prescription Use (Part 21 CFR 801 Subpart D) Subpart C)

□ Over-The-Counter Use (21 CFR 801

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)

PSC Publishing Services [phone] EF

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page

510(k) Number (if known)

#### K171643

Device Name

Geistlich Bio-Gide® Compressed

Indications for Use (Describe)

Geistlich Bio-Gide® Compressed is indicated for:

- auqmentation around implants placed in immediate extraction sockets.
- augmentation around implants placed in delayed extraction sockets.
- localized ridge augmentation for later implantation.
- alveolar ridge reconstruction for prosthetic treatment.
- filling of bone defects after root resection, cystectomy, removal of retained teeth.
- guided bone regeneration in dehiscence defects.
- guided tissue regeneration procedures in periodontal defects

Type of Use (Select one or both, as applicable)

ഗ് Prescription Use (Part 21 CFR 801 Subpart D) Subpart C)

□ Over-The-Counter Use (21 CFR 801

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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# 2. 510(k) Summary

## GEISTLICH BIO-GIDE® SHAPE

## SPONSOR

Geistlich Pharma AG Bahnhofstrasse 40 CH-6110 Wolhusen Switzerland

| Contact Person: | Marco Steiner |
|-----------------|---------------------------------------------------------------|
| Company: | Geistlich Pharma AG |
| Phone Number: | 011 41 41 492 67 64 (direct)<br>011 41 41 492 55 55 (company) |
| E-mail: | [e-mail] |

Date Prepared: October 26, 2017

## DEVICE NAME

| Proprietary Name: | Geistlich Bio-Gide® Shape |
|----------------------|--------------------------------------|
| Common/Usual Names: | Collagen Resorbable Bilayer Membrane |
| Classification Name: | Bone Grafting Material |
| Product Code: | NPL |

#### PREDICATE DEVICE

Geistlich Bio-Gide® Perio (K112575)

## REFERENCE DEVICE

Geistlich Bio-Gide® (K960724, K042197, K112572)

#### DEVICE DESCRIPTION

Geistlich Bio-Gide® Shape is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells into the membrane, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. The Geistlich Bio-Gide® Shape membrane has a pre-shaped form with a maximum width and height of 14mm x 24mm, respectively. With the exception of the size and shape, Geistlich Bio-Gide® Shape is the same as its predicate device, Geistlich Bio-Gide® Perio (K112575).

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Available Products: Geistlich Bio-Gide® Shape 14 x 24 mm (pre-shaped form)

## INTENDED USE

Geistlich Bio-Gide® Shape is indicated for:

- augmentation around implants placed in immediate extraction sockets.
- augmentation around implants placed in delayed extraction sockets.
- localized ridge augmentation for later implantation.
- alveolar ridge reconstruction for prosthetic treatment.
- filling of bone defects after root resection, cystectomy, removal of retained teeth.
- quided bone regeneration in dehiscence defects.

## SUMMARY OF TECHNOLOGICAL CHARACTERISTICS

Geistlich Bio-Gide® Shape has the similar technological characteristics (e.g., similar design, identical material) as the predicate device Geistlich Bio-Gide® Perio. Geistlich Bio-Gide® Shape has a pre-shaped form with a maximum width and height of 14 mm x 24 mm, respectively, whereas the predicate device, Geistlich Bio-Gide® Perio, is rectangular and has a size of 16 x 22 mm, this difference does not affect the determination of substantial equivalence, as supported by the performance data.

| Characteristic | Geistlich Bio-Gide® Perio<br>(K112575) | Geistlich Bio-Gide® Shape<br>(Proposed) |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <i>Intended Use</i> | | |
| Intended Use/Indications<br>for Use | Geistlich Bio-Gide® Perio is<br>intended to be used for:<br>- augmentation around implants<br>placed in immediate extraction<br>sockets.<br>- augmentation around implants<br>placed in delayed extraction<br>sockets.<br>- localized ridge augmentation for<br>later implantation.<br>- alveolar ridge reconstruction for<br>prosthetic treatment.<br>- filling of bone defects after root<br>resection, cystectomy, removal of<br>retained teeth.<br>- guided bone regeneration in<br>dehiscence defects.<br>- guided tissue regeneration<br>procedures in periodontal<br>defects. | Geistlich Bio-Gide® Shape is<br>intended to be used for:<br>- augmentation around implants<br>placed in immediate extraction<br>sockets.<br>- augmentation around implants<br>placed in delayed extraction<br>sockets.<br>- localized ridge augmentation for<br>later implantation.<br>- alveolar ridge reconstruction for<br>prosthetic treatment.<br>- filling of bone defects after root<br>resection, cystectomy, removal of<br>retained teeth.<br>- guided bone regeneration in<br>dehiscence defects. |

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| Characteristic | Geistlich Bio-Gide® Perio<br>(K112575) | Geistlich Bio-Gide® Shape<br>(Proposed) |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Physical characteristics | | |
| Form | membrane | membrane |
| Dimensions | 16 x 22 mm | 14 x 24 mm (specifically shaped) |
| Composition Materials | | |
| Native collagen | 85 – 100% | 85 – 100% |
| Amino Acid Composition | As standard | As standard |
| Fat | Not more than 1.0% | Not more than 1.0% |
| pH (finished product) | 5.0 - 8.5 | 5.0 - 8.5 |
| Manufacture | | |
| Manufacturing conditions | Same manufacturing conditions | Same manufacturing conditions |
| Viral inactivation | Same viral inactivation step | Same viral inactivation step |
| Packaging | Double blister format. Inner and<br>outer blister made of A-PET.<br>Outer blister covered with<br>polyethylene Tyvek foil. | Double blister format. Inner and<br>outer blister made of A-PET.<br>Outer blister covered with<br>polyethylene Tyvek foil. |

## SUMMARY OF DATA TO SUPPORT SUBSTANTIAL EQUIVALENCE

Geistlich Bio-Gide® Shape is made of the same raw materials and manufactured with the same manufacturing process (except for the cutting step to create the modified shape) hence, the material properties are identical. Further, the same release testing as performed for the predicate is conducted for the subject device and includes determination of appearance, dry residue, sulphated ash, nitrogen total content, nitrogen amide content, fat content, pH value, native collagen, amino acid analysis, sterility test and bacterial endotoxins. Lot testing confirmed that the Geistlich Bio-Gide® Shape meets the specification and is equivalent to Geistlich Bio-Gide®. Usability tests with Geistlich Bio-Gide® Shape confirmed that the device is easy to use for procedures in extraction sockets. Sterilization of the subject device is based on the predicate and reference devices Geistlich Bio-Gide® Perio and Geistlich Bio-Gide® conducted according to the standards ISO 11137-1, ISO 11137-2, ISO 11137-3. ISO 11737-1 and ISO 11737-2, which showed that the devices meet the sterility specification. A viral clearance study in accordance with the requirements of ICH Q5A and ISO 22442-3 was conducted and confirmed sufficient viral clearance capacity of the manufacturing process of the Geistlich Bio-Gide® family of products.

The following biological risks were evaluated according to ISO 10993: cytotoxicity (ISO 10993-5), genotoxicity (ISO 10993-3), carcinogenicity (ISO 10993-3), irritation (ISO 10993-10), sensitization (ISO 10993-10), acute toxicity (ISO 10993-11), subchronic and chronic toxicity (ISO 10993-11) and implantation (local effects; ISO 10993-6). The results demonstrated that the device is biocompatible.

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## SUMMARY OF ANIMAL STUDY DATA

An in vivo animal study was conducted to evaluate the performance of Geistlich Bio-Gide® in facilitating guided bone regeneration around exposed implant threads (K960724). The results showed that treatment with Geistlich Bio-Gide® improved the decrease of defect size after 6 months, as evaluated histologically and by histomorphometry.

#### SUMMARY OF CLINICAL STUDY DATA

The clinical performance of the Geistlich Bio-Gide® family of products has been established based on clinical testing data from the K960724 and K042197 reference devices. A total of 75 patients were recruited in a study to examine the effectiveness and tolerability of Geistlich Bio-Gide® as a barrier membrane for quided bone regeneration in simultaneous implant placement. The results demonstrated the performance of Geistlich Bio-Gide® in combination with Geistlich Bio-Oss for bone regeneration in defects around implants. No serious adverse event or antigenic reaction was observed. Only minor or moderate signs of inflammation, including pain, swelling, redness, hematoma or wound dehiscences were noted and were probably related to the surgical procedure.

Another clinical study involved 15 patients and the application of 16 Geistlich Bio-Gide membranes, which similarly showed that Geistlich Bio-Gide® can be used in defect filling in combination with bone grafting material Geistlich Bio-Oss®.

#### CONCLUSION

Geistlich Bio-Gide® Shape has same subset of indications and identical material properties as the predicate device, Geistlich Bio-Gide® Perio.

Thus, Geistlich Bio-Gide® Shape has the same intended use and similar technological characteristics as the predicate device.

Based on the data provided within this 510(k) submission as summarized above, it can be concluded that Geistlich Bio-Gide® Shape is substantially equivalent to the predicate device, Geistlich Bio-Gide® Perio (K112575), and the reference device, Geistlich Bio-Gide® (K112572).

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## GEISTLICH BIO-GIDE® COMPRESSED

#### SPONSOR

Geistlich Pharma AG Bahnhofstrasse 40 CH-6110 Wolhusen Switzerland

| Contact Person: | Marco Steiner |
|-----------------|---------------------------------------------------------------|
| Company: | Geistlich Pharma AG |
| Phone Number: | 011 41 41 492 67 64 (direct)<br>011 41 41 492 55 55 (company) |
| E-mail: | [e-mail] |

Date Prepared: October 26, 2017

#### DEVICE NAME

| Proprietary Name: | Geistlich Bio-Gide® Compressed |
|----------------------|--------------------------------------|
| Common/Usual Names: | Collagen Resorbable Bilayer Membrane |
| Classification Name: | Bone Grafting Material |
| Product Code: | NPL |

#### PREDICATE DEVICE

Geistlich Bio-Gide® Perio (K112575)

#### REFERENCE DEVICE

Geistlich Bio-Gide® (K960724, K042197, K112572)

#### DEVICE DESCRIPTION

Geistlich Bio-Gide® Compressed is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells into the membrane, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. The Geistlich Bio-Gide® Compressed membrane is available in two different sizes, 13 x 25 mm and 20 x 30 mm. With the exception of the size and a minor difference during manufacturing to mark the dense surface of the membrane, which should face the soft tissue, Geistlich Bio-Gide® Compressed is the same as its predicate device, Geistlich Bio-Gide® Perio.

Available Products: Geistlich Bio-Gide® Compressed 13 x 25 mm Geistlich Bio-Gide® Compressed 20 x 30 mm

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## INTENDED USE

Geistlich Bio-Gide® Compressed is indicated for:

- augmentation around implants placed in immediate extraction sockets.
- augmentation around implants placed in delayed extraction sockets.
- localized ridge augmentation for later implantation.
- alveolar ridge reconstruction for prosthetic treatment.
- filling of bone defects after root resection, cystectomy, removal of retained teeth.
- guided bone regeneration in dehiscence defects.
- guided tissue regeneration procedures in periodontal defects.

## SUMMARY OF TECHNOLOGICAL CHARACTERISTICS

Geistlich Bio-Gide® Compressed has the similar technological characteristics (e.g., similar design, identical material) as the predicate device, Geistlich Bio-Gide® Perio. A manufacturing step has been added that marks the dense surface to indicate that it should face the soft tissue. In addition, the size of Geistlich Bio-Gide® Compressed has been modified. However, this difference does not affect the determination of substantial equivalence, as supported by the performance data and the company's cleared reference device

| Characteristic | Geistlich Bio-Gide® Perio<br>(K112575) | Geistlich Bio-Gide®<br>Compressed<br>(Proposed) |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | | |
| Intended<br>Use/Indications for Use | Geistlich Bio-Gide® Perio is<br>intended to be used for:<br>– augmentation around implants<br>placed in immediate extraction<br>sockets.<br>– augmentation around implants<br>placed in delayed extraction<br>sockets.<br>– localized ridge augmentation<br>for later implantation.<br>– alveolar ridge reconstruction for<br>prosthetic treatment.<br>– filling of bone defects after root<br>resection, cystectomy, removal of<br>retained teeth.<br>– guided bone regeneration in<br>dehiscence defects.<br>– guided tissue regeneration<br>procedures in periodontal<br>defects. | Geistlich Bio-Gide® Compressed<br>is intended to be used for:<br>– augmentation around implants<br>placed in immediate extraction<br>sockets.<br>– augmentation around implants<br>placed in delayed extraction<br>sockets.<br>– localized ridge augmentation<br>for later implantation.<br>– alveolar ridge reconstruction for<br>prosthetic treatment.<br>– filling of bone defects after root<br>resection, cystectomy, removal of<br>retained teeth.<br>– guided bone regeneration in<br>dehiscence defects.<br>– guided tissue regeneration<br>procedures in periodontal<br>defects. |

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| Characteristic | Geistlich Bio-Gide® Perio<br>(K112575) | Geistlich Bio-Gide®<br>Compressed<br>(Proposed) |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Physical characteristics | | |
| Form | membrane | membrane |
| Dimensions | 16 x 22 mm | 13 x 25 mm<br>20 x 30 mm |
| Composition Materials | | |
| Native collagen | 85 – 100% | 85 – 100% |
| Amino Acid<br>Composition | As standard | As standard |
| Fat | Not more than 1.0% | Not more than 1.0% |
| pH (finished product) | 5.0 - 8.5 | 5.0 - 8.5 |
| Manufacture | | |
| Manufacturing<br>conditions | Same manufacturing conditions | Same manufacturing conditions |
| Viral inactivation | Same viral inactivation step | Same viral inactivation step |
| Packaging | Double blister format. Inner and<br>outer blister made of A-PET.<br><br>Outer blister covered with<br>polyethylene Tyvek foil. | Double blister format. Inner and<br>outer blister made of A-PET.<br><br>Outer blister covered with<br>polyethylene Tyvek foil. |

## SUMMARY OF DATA TO SUPPORT SUBSTANTIAL EQUIVALENCE

Geistlich Bio-Gide® Compressed is made of the same raw materials and manufactured with the same manufacturing process (except for the cutting step and marking the device with "UP") as the predicate device. Hence, the material properties are identical. Further, the same release testing is conducted for the subject and predicate devices, which includes determination of appearance, dry residue, sulphated ash, nitrogen total content, nitrogen amide content, fat content, pH value, native collagen, amino acid analysis, sterility test and bacterial endotoxins. Lot testing confirmed that Geistlich Bio-Gide® Compressed meets the specification and is equivalent to Geistlich Bio-Gide®. Usability tests confirmed that Geistlich Bio-Gide® Compressed has appropriate handling properties and is easy to use. Sterilization of the subject device is based on the predicate and reference devices Geistlich Bio-Gide® Perio and Geistlich Bio-Gide® conducted according to the standards ISO 11137-1, ISO 11137-2, ISO 11137-3, ISO 11737-1 and ISO 11737-2, which showed that the devices meet the sterility specification. A viral clearance study in accordance with the requirements of ICH Q5A and ISO 22442-3 was conducted and confirmed sufficient viral clearance capacity of the manufacturing process of the Geistlich Bio-Gide® family of products.

The following biological risks were evaluated according to ISO 10993: cytotoxicity (ISO 10993-5), genotoxicity (ISO 10993-3), carcinogenicity (ISO 10993-3), irritation (ISO 10993-10), sensitization (ISO 10993-10), acute toxicity (ISO 10993-11), subchronic and chronic toxicity (ISO

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10993-11) and implantation (local effects; ISO 10993-6). The results demonstrated that the device is biocompatible.

## SUMMARY OF ANIMAL STUDY DATA

An in vivo animal study was conducted to evaluate the performance of Geistlich Bio-Gide® in facilitating guided bone regeneration around exposed implant threads (K960724). The results showed that treatment with Geistlich Bio-Gide® improved the decrease of defect size after 6 months, as evaluated histologically and by histomorphometry.

## SUMMARY OF CLINICAL STUDY DATA

The clinical performance of the Geistlich Bio-Gide® family of products has been established based on clinical testing data from the K960724 and K042197 reference devices. A total of 75 patients were recruited in a study to examine the effectiveness and tolerability of Geistlich Bio-Gide® as a barrier membrane for guided bone regeneration in simultaneous implant placement. The results demonstrated the performance of Geistlich Bio-Gide® in combination with Geistlich Bio-Oss for bone regeneration in defects around implants. No serious adverse event or antigenic reaction was observed. Only minor or moderate signs of inflammation, including pain, swelling, redness, hematoma or wound dehiscences were noted and were probably related to the surgical procedure.

Another clinical study involved 15 patients and the application of 16 Geistlich Bio-Gide membranes, which similarly showed that Geistlich Bio-Gide® can be used in defect filling in combination with bone grafting material Geistlich Bio-Oss®.

In addition, the performance of Geistlich Bio-Gide® in guided tissue regeneration procedures in periodontal defects was evaluated in several clinical studies, as summarized below:

| Defect Type | Subjects | Key Findings |
|----------------------|------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Recession<br>defects | 20 patients, each contributing a<br>pair of Miller Class I or II buccal<br>gingival recessions | Treatment with Geistlich Bio-Gide® resulted in a<br>significant gain of root coverage at 3 months and<br>decrease of recess depth at 6 months. |
| Furcation<br>defects | A total of 52 grade II mandibular<br>molar furcation defects | The experimental group combined Bio-Oss® and<br>Bio-Gide® presented with significantly greater<br>pocket reduction, gain in clinical attachment level<br>(CAL), vertical defect fill and horizontal defect fill<br>compared to the control group (SCTG). |
| | 21 patients with 31 furcation<br>defects | There was a statistically significant improvement in<br>most clinical indices for the Bio-Oss®/ Bio-Gide®<br>group. |

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| Intrabony<br>defects | 22 paired intrabony defects | Postoperative pocket depths, attachment levels and<br>transoperative bone measurements were similar for<br>control (open-flap debridement) and experimental<br>(bovine porous bone mineral and Geistlich Bio-<br>Gide®) sites. |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 28 patients suffering from<br>chronic periodontitis, and each<br>of whom displayed one<br>intrabony defect | No differences in any of the investigated parameters<br>at baseline between Bio-Gide® treatment and<br>access flap surgery (AFS). At 1 year after surgery<br>both therapies resulted in significant gains of clinical<br>attachment level (CAL) and probing depth (PD)<br>reductions. The Bio-Gide® treatment group resulted<br>in significantly higher CAL gains than treatment with<br>AFS. |
| | 124 patients with advanced<br>chronic periodontitis, each with<br>at least one intrabony defect of<br>no less than 3mm | The Bio-Gide® test group showed a significantly<br>higher gain in CAL and pocket reduction compared<br>to the controls. |
| | 4 intrabony defects, two<br>received Geistlich Bio-Gide®<br>alone and two were treated with<br>a combination of Bio-Oss®/ Bio-<br>Gide® | Both treatments were shown to significantly improve<br>clinical probing depths and attachment levels, and<br>the radiographic appearance suggested osseous fill.<br>The regenerative effect was more pronounced with<br>Bio-Gide®. Histologic evaluation revealed that both<br>treatments produced new cementum with inserting<br>collagen fibers and new bone formation on the<br>surface of the graft particles. |
| | 4 intrabony defects, two<br>received Geistlich Bio-Gide®<br>alone and two were treated with<br>a combination of Bio-Oss®/ Bio-<br>Gide® | Use of Bio-Oss® in combination with / Bio-Gide®<br>resulted in a complete new attachment apparatus,<br>evidencing periodontal regeneration that varied with<br>defect morphology. |

The above studies also showed a favorable safety profile for Geistlich Bio-Gide®, with no serious adverse events noted.

## CONCLUSION

In summary, Geistlich Bio-Gide® Compressed has the same indications and identical material properties as the predicate device, Geistlich Bio-Gide® Perio. The sizes of Geistlich Bio-Gide® Compressed have been modified and a marking step is included during manufacture, but these differences are minor and do not affect the performance of the device, as supported by the testing conducted.

Based on the data provided within this 510(k) submission as summarized above, it can be concluded that Geistlich Bio-Gide® Compressed is substantially equivalent to the Geistlich Bio-Gide® Perio, the predicate device.