(16 days)
Versaclose is indicated for use in soft tissue approximation for procedures such as general and orthopedic surgery.
The Versaclose implant is comprised of one (1) Peek Optima (LT1) Toggle-anchor, connected to an adjustable 2-0 braided suture loop, made of ultra high molecular weight polyethylene (UHMWPE) force fiber suture. The suture component conforms to USP requirements. The construct is provided sterile and preloaded on a disposable delivery instrument.
Here's an analysis of the provided text regarding the Versaclose™ device, focusing on the acceptance criteria and supporting study information:
Based on the provided document, the Versaclose™ device's regulatory submission (K100572) is primarily focused on demonstrating substantial equivalence to a predicate device (K061386 - Anchor Band Suturing System) rather than proving performance against specific, quantitative acceptance criteria through a clinical or performance study as might be expected for an AI/diagnostic device.
Key takeaway: This document describes a device modification where the primary evidence for meeting acceptance criteria is through design verification and validation activities, specifically tensile testing to confirm compliance with USP suture requirements. It is not a clinical study of the type often associated with AI performance evaluations.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated) | Reported Device Performance |
|---|---|
| Compliance to USP suture requirements (identified via risk analysis) | "tensile testing was performed to confirm compliance to USP suture requirements." |
Note: The document does not provide the specific numerical values for USP suture requirements (e.g., minimum tensile strength for a 2-0 braided suture) or the specific numerical results obtained from the tensile testing. It only states that compliance was confirmed.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "tensile testing" but does not specify the number of samples or lots tested.
- Data Provenance: Not applicable in the context of a retrospective/prospective study with human subjects. The testing described is a physical characterization of the device itself.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. The "ground truth" for this type of submission is defined by the USP (United States Pharmacopeia) standards for sutures, which are published material specifications, not expert consensus on medical images or diagnoses.
4. Adjudication Method for the Test Set
- Not applicable. There is no human adjudication process described for the tensile testing or USP compliance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement
- No. This type of study (MRMC) is generally performed for diagnostic or AI-assisted interpretation devices to assess the impact on human readers. This submission is for a surgical implant/suturing system, and such a study is not relevant here.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop) Performance Was Done
- No. This is not an algorithm or AI device. The described testing is a standalone device performance test in a laboratory setting (tensile testing) to confirm material properties, not an algorithm's classification performance.
7. The Type of Ground Truth Used
- Material Specification / Standard: The ground truth for the "acceptance criteria" is the USP (United States Pharmacopeia) requirements for sutures. These are pre-defined, standardized physical and mechanical properties that sutures must meet.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" in the context of this device submission for a physical medical device. The "training" here would be related to the development and refinement of the device design, which is not described in terms of a data set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set in the AI/diagnostic sense, there is no ground truth established for one. The "ground truth" for the device's design and manufacturing is adherence to general engineering principles, material specifications, and quality systems.
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K100572_
Section 5 – 510(k) Summary
t
| Applicant: | Anulex Technologies, Inc.5600 Rowland Road, Suite 280Minnetonka, MN 55343 | MAR 1 7 2010 |
|---|---|---|
| Contact Person: | Rachel KennedyDirector of Regulatory and Quality SystemsTelephone: 952.224.4034Fax: 952.224.4040e-mail: rkennedy@anulex.com | |
| Date Prepared: | February 26, 2010 | |
| Trade Name: | Versaclose™ | |
| Product Classificationand Code: | 21 CFR §878.5000Class: IIProduct Code: GAT | |
| Predicate Device: | K061386 - Anchor Band Suturing System | |
| Device Description: | The Versaclose implant is comprised of one (1) Peek Optima(LT1) Toggle-anchor, connected to an adjustable 2-0 braidedsuture loop, made of ultra high molecular weight polyethylene(UHMWPE) force fiber suture. The suture componentconforms to USP requirements. The construct is providedsterile and preloaded on a disposable delivery instrument. | |
| Intended Use: | Versaclose is indicated for use in soft tissue approximation forprocedures such as general and orthopedic surgery. | |
| Summary ofTechnologicalCharacteristics: | The modifications to the Anchor Band Suturing System wereconducted in accordance with the Anulex Design ControlSystem. Accordingly, the risk analysis identified necessarydesign verification and validation activities. As a result ofthis analysis, tensile testing was performed to confirmcompliance to USP suture requirements. | |
| Conclusion: | The modified Anchor Band Suturing System (Versaclose) issubstantially equivalent to the original Anchor Band SuturingSystem in regards to the indications for use, technology andthe basic operating principle. |
CONFIDENTIAL
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Image /page/1/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of a bird.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Anulex Technologies, Inc. % Ms. Rachel Kennedy Director of Regulatory & Quality Systems 5600 Rowland Road, Suite 280 Minnetonka, Minnesota 553430
MAR 1 7 2010
Re: K100572
Trade/Device Name: Versaclose™ Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: II Product Code: GAT Dated: February 26, 2010 Received: March 1, 2010
Dear Ms. Kennedy:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Julie Acker, RAC Ms. Rachel Kennedy
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,
for Peta) R
Mark N. Miller
Mark N. Melkerso Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
- KIO0572 510(k) Number (if known):
Device Name:
Versaclose™ is indicated for use in soft tissue approximation for procedures such as general and orthopedic surgery.
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Keane for MXM
(Division (Division of Surgical, Orthopedic, and Restorative Devices
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510(k) Number K100572
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.