INQU PASTE MIX PLUS

K103799 · Isto Technologies, Inc. · MQV · Aug 29, 2011 · Orthopedic

Device Facts

• Record ID: K103799
• Device Name: INQU PASTE MIX PLUS
• Applicant: Isto Technologies, Inc.
• Product Code: MQV · Orthopedic
• Decision Date: Aug 29, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

InQu® is a resorbable bone void filler intended to fill bony gaps or voids that are not intrinsic to the stability of the bony structure. InQu® is intended for use as a bone graft substitute in the skeletal system (extremities and pelvis) and as a bone graft extender in the spine when combined with bone autograft. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

Device Story

InQu® Paste Mix Plus is a sterile, synthetic, resorbable bone void filler; composed of poly (D,L-lactide-co-glycolide), hyaluronic acid, and sodium carboxymethylcellulose. Provided as a powder to be mixed with a fluid (saline or blood) at the time of use to form a putty. Used by surgeons in clinical settings to fill bony voids; material resorbs and is replaced by bone during healing. Device improves handling characteristics compared to previous iterations.

Clinical Evidence

Bench testing only. Study compared dissolution rate and characteristics of smaller granule size in Paste Mix Plus to predicate devices; results showed no significant differences.

Technological Characteristics

Synthetic bone void filler; materials: poly (D,L-lactide-co-glycolide), hyaluronic acid, sodium carboxymethylcellulose. Form: granular powder mixed with fluid to form putty. Resorbable. Single patient use.

Indications for Use

Indicated for patients with bony gaps or voids in the skeletal system (extremities and pelvis) not intrinsic to structural stability; also indicated as a bone graft extender in the spine when combined with autograft. Applicable to surgically created or traumatic osseous defects.

Regulatory Classification

Identification

A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.

Predicate Devices

• InQu® ISTO Technologies, Inc. (K063359)
• InQu® ISTO Technologies, Inc. (K071428)
• CarriGen Porous Bone Substitute, ETEX Corp. (K093447)

Submission Summary (Full Text)

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K103799

Submitter:
ISTO Technologies, Inc.

InQu® Paste Mix Plus Traditional 510(k)

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| Submitter Name: | ISTO Technologies, Inc. | AUG 2 9 2011 |
|----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Submitter Address: | 1155 Olivette Executive Parkway, Suite 200<br>St. Louis, Missouri 63132 | |
| Contact Person: | Penny White<br>Vice President, Regulatory Affairs and Quality Assurance | |
| Direct Number: | 314-262-8007 | |
| Company Main Number: | 314-995-6049 | |
| Fax Number: | 314-995-6025 | |
| Date Prepared: | December 21, 2010 | |
| Device Trade Name: | InQu® Paste Mix Plus | |
| Device Common Name:<br>Classification Name:<br>Classification Number:<br>Product Code: | Resorbable bone void filler<br>Filler, bone void, calcium salt compound<br>21 CFR 888.3045<br>MQV | |
| Predicate Devices: | InQu® ISTO Technologies, Inc., K063359<br>InQu® ISTO Technologies, Inc., K071428<br>CarriGen Porous Bone Substitute, ETEX Corp., K093447 | |
| Statement of<br>Intended Use: | InQu® is a resorbable bone void filler intended to fill bony gaps or<br>voids that are not intrinsic to the stability of the bony structure. InQu®<br>is intended for use as a bone graft substitute in the skeletal system<br>(extremities and pelvis) and as a bone graft extender in the spine<br>when combined with bone autograft. These defects may be surgically<br>created osseous defects or osseous defects created from traumatic<br>injury to the bone. The product provides a bone void filler that resorbs<br>and is replaced with bone during the healing process. | |
| Device Description,<br>Summary of<br>Technological<br>Characteristics | InQu® Paste Mix Plus is intended for single patient use only. The<br>device is a sterile, granular, synthetic bone void filler composed of<br>poly (D,L-lactide-co-glycolide), hyaluronic acid and sodium carboxy-<br>methylcellulose provided in powder form, added to improve handling<br>characteristics. The two components are mixed at the time of use and<br>combined with a fluid (e.g. saline or blood) to form a putty, which is<br>easily placed into bony voids. It resorbs and is replaced with bone<br>during the healing process. | |
| Device Testing | ISTO performed a study comparing the dissolution rate and<br>characteristics of the smaller granule size in the Paste Mix Plus to the<br>granules in the predicate devices. The results show the two forms do<br>not have significant differences. | |
| Comparison to the<br>Predicate Device | The new device is substantially equivalent to the predicate devices in<br>terms of intended use, material composition and technological<br>characteristics, as shown in the above testing. | |

Section 5.0

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

ISTO Technologies, Incorporated % Ms. Penny White Vice President, Regulatory Affairs and Quality Assurance 1155 Olivette Executive Parkway, Suite 200 Saint Louis, Missouri 63132

AUG 29 2011

Re: K103799

Trade/Device Name: InQue Paste Mix Plus Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: August 16, 2011 Received: August 17, 2011

Dear Ms. White:

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

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Page 2 - Ms. Penny White

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Enclosure

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

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| 510(k) Number (if known): | K103799 |
|---------------------------|---------|
|---------------------------|---------|

Device Name:

InQu® Paste Mix Plus

Indications for Use:

InQuy is a resorbable bone void filler intended to fill bony gaps or voids that are not intrinsic to the stability of the bony structure. InQue is intended for use as a bone graft substitute in the skeletal system (extremities and pelvis). InQu® is indicated for use as a bone graft extender in the spine when combined with bone autograft. These defects may be surgically created osseous defects, or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

Prescription Use x (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K103799