GELITA-SPON ABSORBABLE GELATIN SPONGE, USP

K060878 · Curamedical, BV · KHJ · Apr 13, 2006 · Ear, Nose, Throat

Device Facts

• Record ID: K060878
• Device Name: GELITA-SPON ABSORBABLE GELATIN SPONGE, USP
• Applicant: Curamedical, BV
• Product Code: KHJ · Ear, Nose, Throat
• Decision Date: Apr 13, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 874.3620
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Gelita-Spon® Absorbable Gelatin Sponge, USP is indicated for use to control minimal bleeding by tamponade effect, blood absorption and platelet aggregation following ENT surgery and also to prevent adhesions in the nasal cavity.

Device Story

Gelita-Spon is a sterile, absorbable, porcine-derived gelatin sponge; used in ENT surgery settings by clinicians. Device functions via hygroscopic properties; absorbs blood (up to 50 times its weight); forms gelatinous mass upon contact with fluids; provides tamponade effect; promotes platelet aggregation; prevents nasal adhesions. Implanted in vivo; completely resorbed within approximately 3 weeks; residues removed via gentle irrigation or natural resorption. Provides hemostasis and physical barrier to aid post-surgical healing.

Clinical Evidence

Bench testing only. No clinical data presented. Device demonstrated compliance with USP test criteria and biocompatibility standards.

Technological Characteristics

Material: Porcine-derived gelatin (collagen). Form: Absorbable sponge. Principle: Hygroscopic, forms gelatinous mass. Sterilization: Gamma radiation. Resorption: Within 21 days. Biocompatibility: ISO 10993 and USP compliant.

Indications for Use

Indicated for patients undergoing ENT surgery to control minimal bleeding via tamponade, blood absorption, and platelet aggregation, and to prevent nasal cavity adhesions.

Regulatory Classification

Identification

Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.

Predicate Devices

• Gelita-Spon® Absorbable Gelatin Sponge (K051911)

Submission Summary (Full Text)

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Submitter: CuraMedical, B.V.

### 510(k) Summary

510(k) Summary

K060878

APR 2 0 2006

| Submitter Name: | CuraMedical, BV |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | Osdorperweg 590 Amsterdam, NL-1067 SZ, The Netherlands |
| Phone Number: | 011 31 20 667 5330 |
| Fax Number: | 011 31 20 667 5331 |
| Contact Person: | Rik Van Beek |
| Date Prepared: | 26 March 2006 |
| Device Trade Name: | Gelita-Spon® Absorbable Gelatin Sponge, USP (Gelita-Spon) |
| Common Name | Gelatin Sponge |
| Classification Name, Number & Product Code: | Intranasal Splint (21 CRF 874.4780) LYA; Ear, Nose and Throat Synthetic Polymer Material (21 CRFR 874.3620) KHJ |
| Predicate Devices: | Gelita-Spon® Absorbable Gelatin Sponge |
| Device Description and Statement of Intended Use | Gelita-Spon® Absorbable Gelatin Sponge USP is a sterile absorbable gelatin sponge composed of highly purified pH neutral pharmaceutical gelatin of porcine origin with haemostatic effect suitable for the control of bleeding and as a packing material. It is able to absorb blood corresponding to about 50 times its own weight and when implanted in vivo, it is completely absorbed within approximately 3 weeks. Gelita-Spon is identical to the predicate device in components, composition, specification, manufacture and packaging. Additional testing to confirm compliance with all test criteria in the USP, specifically including certain biocompatibility tests the methodology of which are slightly different from ISO 10993, was performed following FDA guidance in order to append 'USP' to the product name. Gelita-Spon® Absorbable Gelatin Sponge USP is indicated for use to control minimal bleeding by tamponade effect, blood absorption and platelet aggregation following ENT surgery and also to prevent adhesions in the nasal cavity. |

Section 3: 510(k) Summary

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| Submitter:<br>CuraMedical, B.V. | Gelita-Spon® Absorbable Gelatin Sponge, USP<br>Premarket Notification Special 510(k) |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of<br>Technological<br>Characteristics | A table comparing Gelita-Spon to the predicate devices is attached.<br>This comparison demonstrates the substantial equivalence of Gelita-<br>Spon to the predicate devices. |
| Conclusion | The information discussed above demonstrates that Gelita-Spon®<br>Absorbable Gelatin Sponge, USP is as safe, as effective, and performs<br>as well as or better than the predicate device, Gelita-Spon® Absorbable<br>Gelatin Sponge. |
| Declarations | This summary includes only information that is also covered in the body of the 510(k). This summary does not contain any puffery or unsubstantiated labeling claims. This summary does not contain any raw data, i.e., contains only summary data. This summary does not contain any trade secret or confidential commercial information. |

- This summary does not contain any patient identification information. 0

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| Feature | Gelita-Spon® Absorbable Gelatin<br>Sponge, USP | Gelita-Spon® Absorbable Gelatin<br>Sponge |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | | K051911 |
| Manufacturer | CuraMedical, B.V. | CuraMedical, B.V. |
| Classification # &<br>Product Code | 21 CFR 874.4780 and 21 CFR<br>874,3620<br>LYA/KHJ | 21 CFR 874.4780 and 21 CFR 874.3620<br>LYA/KHJ |
| Intended Use | To control minimal bleeding by<br>tamponade effect, blood<br>absorption and platelet<br>aggregation following ENT<br>surgery and also to prevent<br>adhesions in the nasal cavity | To control minimal bleeding by<br>tamponade effect, blood absorption<br>and platelet aggregation following<br>ENT surgery and also to prevent<br>adhesions in the nasal cavity |
| Material/Construc<br>tion | Porcine-derived gelatin (derived<br>from collagen) | Porcine-derived gelatin (derived from<br>collagen) |
| Absorbent<br>Qualities | 40 times weight of the device | 40 times weight of the device |
| Sterility | Gamma radiation | Gamma radiation |
| Resorption Time | Within 21 days | Within 21 days |
| Biocompatibility | ISO 10993 and USP | ISO 10993 |
| Method of Action | Hygroscopic, forms gelatinous<br>mass in contact with fluids | Hygroscopic, forms gelatinous mass<br>in contact with fluids |
| Method of<br>Removal | Gentle irrigation of residues or<br>natural resorption | Gentle irrigation of residues or natural<br>resorption |

#### Summary of Technical Characteristics

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure, represented by three curved lines that suggest the head, body, and tail feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 3 2006

CuraMedical B.V. c/o Mr. William F. Greenrose OServe America, Inc. 220 River Road Claremont, NH 03743

Re: K060787

Trade/Device Name: CuraMedical's Gelita-Spon® Absorbable Gelatin Sponge, USP Regulation Number: 21 CFR 874.3620 Regulation Name: ENT Synthetic Polymer Material Regulatory Class: Class II Product Code: KHJ; LYA Dated: March 29, 2006 Received: March 31, 2006

Dear Mr. Greenrose:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

{4}------------------------------------------------

## Page 2 -- Mr. William F. Greenrose

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Malvina B. Eydelman, M.D. Division Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 2.0

# Indications for Use Statement

510(k) Number (if known):

Gelita-Spon® Absorbable Gelatin Sponge, USP (Gelita-Spon®) Device Name:

### Indications for Use:

Gelita-Spon® Absorbable Gelatin Sponge, USP is indicated for use to control minimal Oclita Open® Aboorbades oct, blood absorption and platelet aggregation following ENT surgery and also to prevent adhesions in the nasal cavity.

### (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH; Office of Device Evaluation (ODE)

X Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

Karin Bohn

(Division Sign-Off) Division of Ophthalmic E Nose and Throat De

510(k) Number

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

APR 2 0 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

CuraMedical B.V. c/o Mr. William F. Greenrose OServe America, Inc. 220 River Road Claremont, NH 03743

Re: K060878

Trade/Device Name: Gelita-Spon® Absorbable Gelatin Sponge, USP Regulation Number: 21 CFR 874.3620 Regulation Name: ENT Synthetic Polymer Material Regulatory Class: II Product Code: KHJ, LYA Dated: March 29, 2006 Received: March 31, 2006

Dear Mr. Greenrose:

This letter corrects our substantially equivalent letter of April 13, 2006.

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 (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.

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 mav 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

{7}------------------------------------------------

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

M.B. Eychhaus - M.D.

Malvina B. Eydelman, M.D. Division Director Division of Ophthalmic and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{8}------------------------------------------------

#### Section 2.0

### Indications for Use Statement

510(k) Number (if known):

Gelita-Spon® Absorbable Gelatin Sponge, USP (Gelita-Spon®) Device Name:

#### Indications for Use:

Gelita-Spon® Absorbable Gelatin Sponge, USP is indicated for use to control minimal bleeding by tamponade effect, blood absorption and platelet aggregation following ENT surgery and also to prevent adhesions in the nasal cavity.

### (PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH; Office of Device Evaluation (ODE)

Prescription × Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

Keren Parker

on Sian-C sion of Ophthalmic Nose and Throat D

510(k) Number F060878