(89 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). 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.
InQu Paste Mix 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) and hyaluronic acid. InQu is combined with a fluid (e.g. saline or blood) to form a paste, which is easily placed into bony voids. It resorbs and is replaced with bone during the healing process.
Here's an analysis of the provided text regarding the acceptance criteria and study for the InQu® Paste Mix device:
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It is not a detailed clinical study report and therefore does not contain the level of detail typically found in such reports regarding acceptance criteria, sample sizes, ground truth establishment, or clinical performance metrics like sensitivity, specificity, or reader studies. The "study" mentioned is a bench study, not a clinical trial.
Acceptance Criteria and Study Details for InQu® Paste Mix
Based on the provided K1118358 510(k) summary, the device is a resorbable bone void filler. The "acceptance criteria" and "study" described are focused on demonstrating substantial equivalence (specifically, dissolution characteristics) to a previously cleared predicate device, rather than proving clinical performance against a set of predefined clinical metrics.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench Test) | Reported Device Performance |
|---|---|
| Dissolution rate and characteristics of smaller granule size in Paste Mix should not have significant differences compared to granules in predicate devices. | The results show the two forms (smaller granule size in Paste Mix vs. granules in predicate devices) do not have significant differences in dissolution rate and characteristics. |
Explanation: This criterion is for a bench test comparing material properties. It is not a clinical acceptance criterion. The "reported device performance" is a direct statement of equivalence from the summary.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified. The document refers to a "study comparing the dissolution rate and characteristics," but does not provide details on the number of samples or replicates used in this bench test.
- Data Provenance: The study was "performed" by ISTO Technologies, Inc. This would typically be a laboratory/bench study. There is no mention of country of origin for data as it's not a human-subjects study. It's a prospective bench test designed for the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. This was a bench test evaluating material properties (dissolution rate and characteristics) under laboratory conditions, not a study requiring expert clinical interpretation or ground truth establishment in a human-subjects context.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. As this was a bench test for dissolution characteristics, there would be no need for clinical adjudication. The assessment would likely involve objective measurements and statistical comparison.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. The document describes a bench study comparing material properties, not a clinical study involving human readers or cases to assess diagnostic or treatment effectiveness.
6. Standalone Performance (Algorithm Only without Human-in-the-loop Performance)
- Was a standalone study done? No. This device is a resorbable bone void filler, not an algorithm or AI-powered device. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply.
7. Type of Ground Truth Used
- Type of Ground Truth: Not applicable in the traditional sense of clinical ground truth (e.g., pathology, outcomes data). For the bench study, the "ground truth" or reference was likely the established behavior/characteristics of the predicate devices' granules, measured objectively in a laboratory setting. The comparison sought to confirm that the new device's granules exhibited similar dissolution properties.
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a training set. The study described is a bench test.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this type of device.
{0}------------------------------------------------
K1118358
Submitter:
ISTO Technologies, Inc.
InQu® Paste Mix
Traditional 510(k)
Section 5.0
510(k) Summary
SEP 2 6 2011
| Submitter Name: | ISTO Technologies, Inc. |
|---|---|
| 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: | June 27, 2011 |
| Device Trade Name: | InQu ® Paste Mix |
| Device Common Name: | Resorbable bone void filler |
| Classification Name: | Filler, bone void, calcium salt compound |
| Classification Number: | 21 CFR 888.3045 |
| Product Code: | MQV |
| Predicate Devices: | InQu ® ISTO Technologies, Inc., K063359InQu ® ISTO Technologies, Inc., K071428 |
| 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). InQu ® is indicated for use as a bone graftextender in the spine when combined with bone autograft. Thesedefects may be surgically created osseous defects, or osseousdefects created from traumatic injury to the bone. The productprovides a bone void filler that resorbs and is replaced with boneduring the healing process. |
| Device Description,Summary ofTechnologicalCharacteristics | InQu ® Paste Mix is intended for single patient use only. The device isa sterile, granular, synthetic bone void filler composed of poly (D,L-lactide-co-glycolide) and hyaluronic acid. InQu is combined with afluid (e.g. saline or blood) to form a paste, which is easily placed intobony voids. It resorbs and is replaced with bone during the healingprocess. |
| Device Testing | ISTO performed a study comparing the dissolution rate andcharacteristics of the smaller granule size in the Paste Mix 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. |
·
រឿ
ﯿﻦ
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows a logo with a circular border containing text. Inside the circle is a stylized image of an eagle or bird in flight, represented by three curved lines that suggest movement and wings. The text around the border appears to be part of an organization's name, possibly related to health or human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20903-0002
ISTO Technologies. Incorporated % Ms. Penny White Vice President, Regulatory Affairs and Quality Assurance 1155 Olivette Executive Parkway, Suite 200 Saint Louis, Missouri 63132
Re: K111838
SEP. 26, 2011
Trade/Device Name: InQui® Paste Mix 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 10 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
{2}------------------------------------------------
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.
ff 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/ReportalProblem/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 vours.
Eunel Keith
Sr Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
| 510(k) Number (if known): | KII1438 |
|---|---|
| --------------------------- | --------- |
Device Name:
InQu® Paste Mix
Indications for Use:
InQue 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). InQue 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 (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)
signature
(Division S Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111838
§ 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.