(260 days)
The Mitek BioKnotless Suture Anchor is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows: Shoulder; Bankhart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsulolabral reconstruction, biceps tenodesis, deltoid repair. Ankle; Lateral instability, medial instability, Achilles tendon repair/reconstruction, midfoot reconstruction. Foot; Hallux Valgus reconstruction. Elbow; Tennis elbow repair, Biceps tendon reattachment. Knee; Extra capsular repairs, reattachment of: medial collateral ligament, lateral collateral ligament, posterior oblique ligament or joint capsule to tibia and joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions.
The device described in this 510(k) is a sterile, preloaded, disposable, absorbable suture anchor/inserter assembly designed to allow soft tissue repair to bone. The product is designed for single patient use only. The anchor is constructed of Polylactic Acid (PLA) and the Panacry)™ suture is a braided long term absorbable suture.
This document describes the BioKnotless Anchor, a sterile, preloaded, disposable, absorbable suture anchor/inserter assembly designed for soft tissue repair to bone. The information provided outlines the safety and effectiveness summary as required for a 510(k) premarket notification.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or a specific table detailing such criteria. However, it mentions the types of tests performed and the conclusion regarding substantial equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Integrity: Anchor pullout strength from bone. | "Anchor pullout from bone testing... were conducted on the device." Data "supported the substantial equivalence." |
| In Vitro Performance: Other in vitro mechanical characteristics. | "...and in vitro testing were conducted on the device." Data "supported the substantial equivalence." |
| Biocompatibility: Meet established biocompatibility standards. | "Biocompatibility testing (according to the FDA guidance document, ODE Blue Book Memorandum #G95-1, 1995, Use of International Standard ISO-10933, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" were performed..." Data "supported the substantial equivalence." |
| Substantial Equivalence: To predicate devices (Mitek - Knotless Anchor and Mitek - Panalok™ Wedge Anchor). | "Based on the Indications for Use, technological characteristics and safety and performance testing, the BioKnotless Anchor has been shown to be substantially equivalent to predicate devices..." |
2. Sample sized used for the test set and the data provenance
The document does not specify the sample sizes for the functional and integrity bench testing or the biocompatibility testing. The data provenance is not explicitly stated beyond the mention of "bench testing" and "in vitro testing," which generally implies laboratory-controlled studies. There is no information regarding country of origin or whether the data was retrospective or prospective in a clinical sense, as these were bench and in vitro tests, not human studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable. The study involved bench testing and in vitro performance, not expert-derived ground truth as would be relevant for diagnostic AI/medical imaging devices. The "ground truth" here would be the physical properties and performance measured directly by scientific methods and instrumentation.
4. Adjudication method for the test set
This section is not applicable for the type of testing described (bench and in vitro performance). Adjudication methods like 2+1 or 3+1 are used in clinical trials or studies involving expert interpretation, which is not the case here.
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
No, an MRMC comparative effectiveness study was not done. This device is a physical surgical anchor, not an AI or diagnostic imaging device that involves human readers or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This section is not applicable. The BioKnotless Anchor is a physical medical device, not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's evaluation was based on objective, measurable physical and chemical properties and performance characteristics. This includes:
- Mechanical Strength: Measured through tests like anchor pullout from bone.
- In Vitro Performance: Other measurable mechanical properties under laboratory conditions.
- Biocompatibility: Assessment against established international standards (ISO-10933), likely involving laboratory assays and material characterization.
These are not "expert consensus," "pathology," or "outcomes data" in the traditional sense, but rather direct measurements of the device's physical and biological interactions.
8. The sample size for the training set
This section is not applicable. There is no "training set" in the context of evaluating a physical medical device like a surgical anchor. Training sets are relevant for machine learning algorithms.
9. How the ground truth for the training set was established
This section is not applicable, as there is no training set for this type of device evaluation.
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MAY 1 1 2001
SUMMARY OF SAFETY & EFFECTIVENESS
Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Mitek Products is required to submit with this Premarket Notification either an " ... adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Mitek Products choose to submit a summary of information respecting safety and effectiveness. According to §513(i)(3)(B), "Any summary under subparagraph (A) respecting a device shall contain detailed information regarding data concerning adverse health effects ... "
The summary regarding the adverse health effects of the proposed BioKnotless Anchor is as follows:
| Trade Name: | BioKnotless Anchor |
|---|---|
| Sponsor: | Mitek Products249 Vanderbilt AvenueNorwood, MA 02062Registration: 1221934 |
| Device Generic Name: | Appliance for reconstruction of bone to soft tissue |
| Classification: | According to Section 13 of the Federal Food, Drug and Cosmetic Act, the deviceclassification is Class II, Performance Standards. |
| Predicate Devices: | Mitek - Knotless AnchorMitek - PanalokTM Wedge Anchor |
All of the devices mentioned above have been determined substantially equivalent by FDA.
Device Description: The device described in this 510(k) is a sterile, preloaded, disposable, absorbable suture anchor/inserter assembly designed to allow soft tissue repair to bone. The product is designed for single patient use only. The anchor is constructed of Polylactic Acid (PLA) and the Panacry)™ suture is a braided long term absorbable suture.
Indications for Use: The BioKnotless Suture Anchor is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows: Shoulder; Bankhart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsulolabral reconstruction, biceps tenodesis, deltoid repair. Ankle; Lateral instability, medial instability, Achilles tendon repair/reconstruction, midfoot reconstruction. Foot; Hallux Valgus reconstruction. Elbow; Tennis elbow repair, Biceps tendon reattachment. Knee; Extra capsular repairs, reattachment of: medial collateral ligament, lateral collateral ligament, posterior oblique ligament or joint capsule to tibia and joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions.
Safety and Performance: Functional and integrity bench testing and Biocompatibility testing (according to the FDA guidance document, ODE Blue Book Memoradum #G95-1, 1995, Use of International Standard ISO-10933, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" were performed, and the data supported the substantial equivalence of the BioKnotless 10 Anchor. Specifically, anchor pullout from bone testing and in vitro testing were conducted on the device.
Conclusion: Based on the Indications for Use, technological characteristics and safety and performance testing, the BioKnotless Anchor has been shown to be substantially eqivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.
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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with three curved lines above them, resembling a stylized bird or wing design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Mary P. LeGraw Manager, Regulatory Affairs Mitek® Products 249 Vanderbilt Avenue Norwood, Massachussetts 02062
MAY 1 1 2001
Re: K002639
Trade Name: BioKnotless Anchor Regulation Number: 21 CFR 878.4493 Regulatory Class: Class II Product Code: GAM and MAI Dated: April 17, 2001 Received: April 20, 2001
Dear Ms.LeGraw:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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.
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Page 2 - Ms. Mary P. LeGraw
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4359. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Amthleelllertonfos
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Devices Evaluation Center for Devices and Radiological Devices
Enclosure
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510(k) Number (if known): _K002633
Device Name: BioKnotless Anchor_
Indications for Use:
The Mitek BioKnotless Suture Anchor is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows:
..............................................................................................................................................................................
Shoulder: Bankhart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsulolabral reconstruction, biceps tenodesis, deltoid repair.
Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction, midfoot reconstruction.
Foot: Hallux Valgus reconstruction
Elbow: Tennis elbow repair, Biceps tendon reattachment.
Knee: Extra capsular repairs, reattachment of: Medial collateral ligament, lateral collateral ligament, posterior oblique ligament or joint capsule to tibia and joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions.
ihuro pis cum
(Division Sign-Off) (Division Sign-On)
Division of General, Restorative
Division of General Devices Division of Gold Devices
510(k) Number K002639
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
X
(Per 21 CFR 801.109)
OR
Over-the -Counter Use _
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved 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.