(197 days)
No
The device description and performance studies focus on the mechanical properties and surgical application of a physical implant, with no mention of software, algorithms, or data processing related to AI/ML.
No.
The device is an implantable suture anchor used for the mechanical fixation of soft tissue to bone, which aids in the healing process but does not directly treat a disease or condition itself.
No
Explanation: The device is an implantable suture anchor used for rotator cuff repair, which is a therapeutic intervention, not a diagnostic one. It functions by reattaching soft tissue to bone.
No
The device description clearly states it is a threaded titanium alloy implantable suture anchor, which is a physical hardware component.
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 Fastin RC Anchor is a threaded titanium alloy implantable suture anchor. It is a physical device surgically implanted into the bone to help reattach soft tissue.
- Intended Use: The intended use is for rotator cuff repair in the shoulder. This is a surgical procedure to fix damaged tissue, not to analyze a specimen from the body.
The description clearly indicates a surgical implant used for mechanical fixation, which falls under the category of a surgical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Fastin RC Anchor is intended for: Shoulder: Rotator cuff repair.
Product codes (comma separated list FDA assigned to the subject device)
MBI, HWC, GAM, GAS
Device Description
The Mitek FASTIN RC Anchor is a threaded titanium alloy implantable suture anchor preloaded on a disposable inserter assembly intended for fixation of two strands of suture. The anchors are designed to be used in the surgical repair of the rotator cuff, and are made from Titanium 6Al-4V ELI per ASTM F-136. The attached suture is then used to reattach soft tissue back to bone where it reconnects through the healing process. Once the tissue has healed (about six weeks) the anchor function is complete and the implant becomes dormant in the bone. The proposed Fastin RC Anchor is available in 5.0mm and 6.5mm sizes and is offered with three suture options, non-absorbable Ethibond, absorbable Panacryl, and composite Orthocord.
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)
Non-clinical laboratory testing was performed demonstrating that the device is safe and performs as intended.
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.
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
K041075 Pge 192
NOV - 9 2004
SECTION 9 – 510(k) SUMMARY
| 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 | Device Regulation:
Staple, Fixation, Bone
(21 CFR 888.3030)
Product codes: MBI, HWC, GAM and GAS
Common/Usual Name:
Staple, Fixation, Bone
Proprietary Name:
Fastin RC Anchor |
| Device Classification | Non-Absorbable Metal Suture Anchors carry FDA product codes MBI,
HWC, GAM & GAS, and are classified as Staple, Fixation, Bone under
21 CFR 888.3030. |
| Indications for Use | The Fastin RC Anchor is intended for:
Shoulder: Rotator cuff repair. |
| Device Description | The Mitek FASTIN RC Anchor is a threaded titanium alloy
implantable suture anchor preloaded on a disposable inserter assembly
intended for fixation of two strands of suture. The anchors are designed
to be used in the surgical repair of the rotator cuff, and are made from
Titanium 6Al-4V ELI per ASTM F-136. The attached suture is then
used to reattach soft tissue back to bone where it reconnects through the
healing process. Once the tissue has healed (about six weeks) the
anchor function is complete and the implant becomes dormant in the |
1
page of
bone. The proposed Fastin RC Anchor is available in 5.0mm and 6.5mm sizes and is offered with three suture options, non-absorbable Ethibond, absorbable Panacryl, and composite Orthocord.
| Substantial Equivalence | The changes being made from the predicate Fastin RC Anchor to the
proposed Fastin RC Anchor are either dimensional or a material
change. The dimensional change is minor (as described in detail in
Section 2 - Device Description) and does not affect the safety or
effectiveness of the device. The second change is a material change to
include a third suture option, composite Orthocord (K040004).
Orthocord suture was previously cleared by FDA for use in general soft
tissue approximation and/or ligation, including use in orthopedic
surgeries. The addition of Orthocord suture option and the dimensional
change made to the design of the anchor does not alter the intended use,
safety and effectiveness or the fundamental scientific technology of the
predicate devices.
Mitek believes that the Fastin RC Anchor is substantially equivalent to
Mitek's existing Fastin RC Anchor (K983818).
A statement of substantial equivalence is provided in Section 3 and the
510(k) "Substantial Equivalence" Decision-Making Process is attached
in Appendix III. |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Safety and Performance | The determination of substantial equivalence for this device was based
on a detailed device description and changes that intend to be made to
currently marketed devices. Non-clinical laboratory testing was
performed demonstrating that the device is safe and performs as
intended. |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
NOV - 9 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Ruth C. Forstadt Project Management Lead, Regulatory Affairs Depuy Mitek A Johnson & Johnson Company 249 Vanderbilt Avenue Norwood, Massachusetts 02062
Re: K041075
Trade/Device Name: Fastin RC Anchors Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HWC, MAI Dated: August 13, 2004 Received: August 16, 2004
Dear Ms. Forstadt:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); 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. Ruth C. Forstadt
This letter will allow you to begin marketing your device as described in your Section 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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,
L. Mark A. Millican
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
Page _ 1 of 1
510(k) Number (if known): K041075
Device Name: Fastin RC Anchors
The Fastin RC Anchors are intended for: Shoulder: Rotator cuff repair.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-Counter Use
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
Premarket Notification: Traditional
Fastin RC Anchors
510(k) Number K041075
Confidential v