(20 days)
The Mitek BIOKNOTLESS RC Anchor is indicated for use in soft tissue to bone fixation in association with adequate post-operative immobilization as follows: Shoulder: Rotator cuff repair.
The BioKnotless RC anchor is a preloaded absorbable disposable suture anchor/inserter assembly designed to allow soft tissue repair to bone without the need for knot tying. The suture assembly is made up of a non-absorbable Ethibond or Panacryl anchor loop and a utility loop constructed of non-absorbable Ethibond Excel suture (green, #2/0). The Ethibond and Panacryl sutures are manufactured by Ethicon, Inc. The absorbable anchor is a one-piece suture anchor constructed of molded Poly(L-lactide) polymer.
This document is a 510(k) Premarket Notification for a medical device called the BioKnotless RC Anchor. It is a submission to the FDA to demonstrate that the new device is substantially equivalent to legally marketed predicate devices, and therefore does not require a new premarket approval application (PMA).
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not specify quantitative acceptance criteria or report specific performance metrics in a structured table. Instead, it makes a general claim:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Anchor to be non-toxic, non-irritating, and non-cytotoxic. | "Biocompatibility studies have demonstrated the BioKnotless RC Anchor to be non-toxic, non-irritating, and non-cytotoxic." |
| Substantial Equivalence to predicate devices (BioKnotless Anchor K002639 and Panalok RC Anchor K964013). | "Mitek believes the BioKnotless RC Anchor is substantially equivalent to the BioKnotless Anchor (K002639) and Panalok RC Anchor (K964013) manufactured by DePuy Mitek." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not detail specific study methodologies, sample sizes, or data provenance (e.g., country of origin, retrospective or prospective) for any performance testing beyond the general mention of "biocompatibility studies." This type of information is typically found in detailed study reports, which are not included in this summary. The 510(k) summary focuses on demonstrating equivalence rather than presenting comprehensive clinical study results.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not applicable and not provided in the document. The context is a 510(k) submission for a medical device (surgical anchor) and not a diagnostic or AI-driven device that would require expert-established ground truth for its performance evaluation.
4. Adjudication Method for the Test Set:
This information is not applicable and not provided in the document. As explained above, this is not a study requiring adjudication of expert interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with imaging diagnostics or AI-assisted diagnostic tools, which is not the case for this surgical anchor. There is no mention of human readers, AI assistance, or an effect size.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Study Was Done:
No, a standalone study (in the context of an algorithm's performance) was not done. The device is a surgical implant, not an algorithm.
7. The Type of Ground Truth Used:
The concept of "ground truth" (e.g., pathology, outcomes data) as it applies to diagnostic or prognostic performance is not directly relevant here. For this device, "ground truth" would be related to its physical and biological properties. The "biocompatibility studies" assessed:
- Toxicity: Whether the material is harmful to living cells/tissue.
- Irritation: Whether it causes an inflammatory response.
- Cytotoxicity: Whether it causes cell death.
The "ground truth" for these assessments would be established through laboratory tests (e.g., in vitro assays, in vivo animal models) following established biocompatibility standards.
8. The Sample Size for the Training Set:
The concept of a "training set" is not applicable here. This is a medical device (surgical anchor), not an AI algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set for an AI algorithm.
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K041064 pg 172
MAY 1 3 2004
510(k) Summary -- BioKnotless RC Anchor
| Submitter's Name andAddress: | DePuy Miteka Johnson & Johnson Company249 Vanderbilt AvenueNorwood, MA 02062 |
|---|---|
| Contact Person | Allyson BarfordRegulatory Affairs AssociateDePuy Miteka Johnson & Johnson Company249 Vanderbilt AvenueNorwood, MA 02062Telephone: 781-251-2794Facsimile: 781-278-9578e-mail: abarford@dpyus.jnj.com |
| Name of Medical Device | Classification Name: Screw, Fixation, Bone StapleCommon/Usual Name: Appliance for reconstruction of bone tosoft tissueProprietary Name: BioKnotless RC Anchor |
| Device Classification | Screw, Fixation, Bone Staple devices have been classified as Class II,GAM and MAI according to 21 CFR 888.3030. No performancestandards have been established under Section 514 of the Food, Drugand Cosmetic Act for Screw, Fixation, Bone Staple devices. |
| Indications for Use | The Mitek BIOKNOTLESS RC Anchor is indicated for use in softtissue to bone fixation in association with adequate post-operativeimmobilization as follows:Shoulder: Rotator cuff repair. |
| Device Description | The BioKnotless RC anchor is a preloaded absorbable disposablesuture anchor/inserter assembly designed to allow soft tissue repair tobone without the need for knot tying. The suture assembly is made upof a non-absorbable Ethibond or Panacryl anchor loop and a utilityloop constructed of non-absorbable Ethibond Excel suture (green, |
Special 510(k) Premarket Notification: BioKnotless RC Anchor
DePuy Mitek
CONFIDENTIAL
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pge 2/2
#2/0). The Ethibond and Panacryl sutures are manufactured by Ethicon, Inc. The absorbable anchor is a one-piece suture anchor constructed of molded Poly(L-lactide) polymer.
Anchor to be non-toxic, non-irritating, and non-cytotoxic.
Based on the type of changes being made and the fact that the Substantial Equivalence BioKnotless RC represents the same fundamental scientific technology as the existing BioKnotless Anchor (K002639) and Panalok RC Anchor (K964013); Mitek believes the BioKnotless RC Anchor is substantially equivalent to the BioKnotless Anchor (K002639) and Panalok RC Anchor (K964013) manufactured by DePuy Mitek. Biocompatibility studies have demonstrated the BioKnotless RC
Safety
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Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized eagle-like symbol with three curved lines representing its wings. The seal is black and white and appears to be a logo or emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 3 2004
Ms. Allyson Barford Regulatory Affairs Associate Depuy Mitek a Johnson & Johnson Company 249 Vanderbilt Avenue Norwood, Massachusetts 02062
Re: K041064
Trade/Device Name: BioKnotless RC Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Codc: JDR and MAI Dated: April 5, 2004 Received: April 23, 2004
Dear Ms. Barford:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosaly to ttg. And enactment date of the Medical Device Amendments, or to commerce prior to May 20, 1978, the eccordance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). and Cosmetic (110) (110) and the device, subject to the general controls provisions of the Act. The 1 ou may) are controls provisions of the Act include requirements for annual registration, listing of general controls pro resurving practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classinod controls. Existing major regulations affecting your device can may be subject to basil as a sublimations, 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 I lease of a rised a determination that your device complies with other requirements of the Act that 1 21 haral statutes and regulations administered by other Federal agencies. You must or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set 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.
{3}------------------------------------------------
Page 2 - Ms. Allyson Barford
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow your to ocean finding of substantial equivalence of your device to a legally premated predicated. " ce results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you dome of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Whisorananing of responsibilities under the Act may be obtained from the Oinor goneral intonnational and Consumer 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 vours,
Sincerely yours,
Mark N. Mellema
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known): K041064
Device Names:
BioKnotless RC Anchor
Indications for Use:
The Mitek BIOKNOTLESS RC Anchor is indicated for use in soft tissue to bone fixation in association with adequate post-operative immobilization as follows: Shoulder: Rotator cuff repair.
l Mark N. Milken
Division of General, Restorative, and Neurological Devices
510(k) Number K091064
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OI
Over-the-Counter Use _ Ab
Special 510(k) Premarket Notification: BioKnotless RC Anchor DePuy Mitek
CONFIDENTIAL
N/A