(244 days)
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.
InQu® Paste Mix Plus is intended for single patient use only. The device is a sterile, granular, synthetic bone void filler composed of poly (D,L-lactide-co-glycolide), hyaluronic acid and sodium carboxymethylcellulose provided in powder form, added to improve handling characteristics. The two components are mixed at the time of use and combined with a fluid (e.g. saline or blood) to form a putty, which is easily placed into bony voids. It resorbs and is replaced with bone during the healing process.
The provided text describes a 510(k) premarket notification for the "InQu® Paste Mix Plus" device, which is a resorbable bone void filler. However, it does not contain a study that establishes acceptance criteria for performance metrics in the way typically seen for AI/ML-based devices with quantitative performance measures. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through material composition, technological characteristics, and dissolution rate.
Therefore, many of the requested categories for AI/ML device studies are not applicable to this 510(k) submission for a medical device that is a bone void filler rather than a diagnostic or predictive algorithm.
Here's a breakdown based on the provided text, addressing the applicable points:
1. A table of acceptance criteria and the reported device performance
The provided text does not present explicit acceptance criteria or quantitative performance metrics in the way an AI/ML study would (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to predicate devices. The study performed focuses on a comparative characteristic.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Dissolution rate and characteristics not significantly different from predicate device granules | "The results show the two forms do not have significant differences." (referring to Paste Mix Plus vs. predicate device granules) |
| Substantially equivalent to predicate devices in terms of intended use, material composition, and technological characteristics | "The new device is substantially equivalent to the predicate devices in terms of intended use, material composition and technological characteristics, as shown in the above testing." |
2. Sample size used for the test set and the data provenance
The document mentions "a study comparing the dissolution rate and characteristics of the smaller granule size in the Paste Mix Plus to the granules in the predicate devices." No specific sample size for this study is provided, nor is the data provenance (e.g., country of origin, retrospective/prospective). This is a physical or chemical property test, not a clinical data test.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The study is comparing physical/chemical properties (dissolution rate) of a bone void filler, not requiring expert consensus on clinical labels or image interpretations.
4. Adjudication method for the test set
Not applicable. This was a physical properties comparison study, not one requiring adjudication of clinical or image data.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a bone void filler, not an AI/ML diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a bone void filler, not an AI/ML algorithm.
7. The type of ground truth used
For the dissolution rate study, the "ground truth" would be the measured dissolution rate and characteristics of the predicate device granules, against which the new device's granules were compared. This is a scientific measurement in a laboratory setting.
8. The sample size for the training set
Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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Submitter:
ISTO Technologies, Inc.
InQu® Paste Mix Plus Traditional 510(k)
| Submitter Name: | ISTO Technologies, Inc. | AUG 2 9 2011 |
|---|---|---|
| Submitter Address: | 1155 Olivette Executive Parkway, Suite 200St. Louis, Missouri 63132 | |
| Contact Person: | Penny WhiteVice 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:Classification Name:Classification Number:Product Code: | Resorbable bone void fillerFiller, bone void, calcium salt compound21 CFR 888.3045MQV | |
| Predicate Devices: | InQu® ISTO Technologies, Inc., K063359InQu® ISTO Technologies, Inc., K071428CarriGen Porous Bone Substitute, ETEX Corp., K093447 | |
| Statement ofIntended Use: | InQu® is a resorbable bone void filler intended to fill bony gaps orvoids 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 spinewhen combined with bone autograft. These defects may be surgicallycreated osseous defects or osseous defects created from traumaticinjury to the bone. The product provides a bone void filler that resorbsand is replaced with bone during the healing process. | |
| Device Description,Summary ofTechnologicalCharacteristics | InQu® Paste Mix Plus is intended for single patient use only. Thedevice is a sterile, granular, synthetic bone void filler composed ofpoly (D,L-lactide-co-glycolide), hyaluronic acid and sodium carboxy-methylcellulose provided in powder form, added to improve handlingcharacteristics. The two components are mixed at the time of use andcombined with a fluid (e.g. saline or blood) to form a putty, which iseasily placed into bony voids. It resorbs and is replaced with boneduring the healing process. | |
| Device Testing | ISTO performed a study comparing the dissolution rate andcharacteristics of the smaller granule size in the Paste Mix Plus to thegranules in the predicate devices. The results show the two forms donot have significant differences. | |
| Comparison to thePredicate Device | The new device is substantially equivalent to the predicate devices interms of intended use, material composition and technologicalcharacteristics, 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 (800) 638-2041 or (301) 796-7100 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
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
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.(b)
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.