(20 days)
Not Found
No
The 510(k) summary describes a mechanical suture anchor and inserter assembly with no mention of AI or ML technology.
No
The device is an orthopedic anchor used for soft tissue to bone fixation, which is a surgical tool rather than a therapeutic device that directly treats a disease or condition.
No
Explanation: The device description states it is a "suture anchor/inserter assembly designed to allow soft tissue repair to bone without the need for knot tying," which indicates it is a surgical tool for treatment, not for diagnosis.
No
The device description clearly describes a physical, implantable suture anchor made of polymers and sutures, which are hardware components. There is no mention of software as part of the device itself.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The Mitek BIOKNOTLESS RC Anchor is a surgical implant used for soft tissue to bone fixation during procedures like rotator cuff repair. It is physically implanted into the body.
- Intended Use: The intended use is for surgical repair of the shoulder, not for analyzing biological samples.
The provided information clearly describes a surgical device, not a device used for testing samples outside the body.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JDR, MAI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility studies have demonstrated the BioKnotless RC Anchor to be non-toxic, non-irritating, and non-cytotoxic.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
K041064 pg 172
MAY 1 3 2004
510(k) Summary -- BioKnotless RC Anchor
| Submitter's Name and
Address: | DePuy Mitek
a Johnson & Johnson Company
249 Vanderbilt Avenue
Norwood, MA 02062 |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Allyson Barford
Regulatory Affairs Associate
DePuy Mitek
a Johnson & Johnson Company
249 Vanderbilt Avenue
Norwood, MA 02062
Telephone: 781-251-2794
Facsimile: 781-278-9578
e-mail: abarford@dpyus.jnj.com |
| Name of Medical Device | Classification Name: Screw, Fixation, Bone Staple
Common/Usual Name: Appliance for reconstruction of bone to
soft tissue
Proprietary 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 performance
standards have been established under Section 514 of the Food, Drug
and Cosmetic Act for Screw, Fixation, Bone Staple devices. |
| 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. |
| Device Description | 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, |
Special 510(k) Premarket Notification: BioKnotless RC Anchor
DePuy Mitek
CONFIDENTIAL
1
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
2
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
4
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