(29 days)
Not Found
No
The summary describes a mechanical suture anchor and driver, with no mention of AI, ML, or related concepts.
No
The device is an implantable suture anchor used for soft tissue repair, which falls under surgical repair devices rather than therapeutic devices. Therapeutic devices are typically used to treat or cure a disease or condition, often through non-surgical means like rehabilitation, monitoring, or drug delivery.
No
The device is described as a suture anchor implant intended for soft tissue repair, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is an injection molded PLLA suture anchor implant pre-loaded with suture and a disposable driver with a stainless steel shaft and ABS handle, indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "soft tissue repair of the shoulder; specifically, Bankhart and SLAP repair, and capsulolabral reconstruction." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The device is a "suture anchor implant pre-loaded with a single strand of the absorbable suture, preloaded onto a disposable driver." This is a surgical implant and delivery system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health.
IVD devices are used to perform tests on samples taken from the human body to diagnose diseases or other conditions. This device is a surgical tool and implant used for repair within the body.
N/A
Intended Use / Indications for Use
The BioAnchor® with Disposable Driver, Preloaded with One #2 Herculine™ Suture is intended for soft tissue repair of the shoulder; specifically, Bankhart and SLAP repair, and capsulolabral reconstruction.
Product codes (comma separated list FDA assigned to the subject device)
MAI, GAT, HWC
Device Description
The BioAnchor® with Disposable Driver, Preloaded with One #2 Herculine™ Suture is an injection molded PLLA suture anchor implant pre-inloaded with a single strand of the #2 Herculine™ suture, preloaded onto a absorbable driver with a stainless steel shaft and ABS handle. The disposable driver will be supplied sterile and single use.
The modification described in this Special 510(K) is to replace the Ethibond Excel suture with a Herculine™ High Strength polyethylene non-absorbable suture.
This modification does not affect the device's intended use, fundamental scientific technology or performance specifications.
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)
Not Found
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
§ 888.3040 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
PROPRIETARY INFORMATION -- LINVATEC CORPORATION
page 1 of 2
October 1, 2004
SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the requirements of the Safe Medical Device Act of 1990
Carperation of the states of the Carperation in horoby submitting the Soecial In accordance with the requirements of the Saveby submitting the Special
and 21 CFR 807.92, Linvates Corporation is hereby submitting the Special and 21 CFR 807.92, Linvate Offportuness for the BioAnchor® with 510(K) Summary of Salety and Enootiveness 71.
Disposable Driver, Preloaded with One #2 Herculine™ Suture 510(K)
Pressure Driver, Preloaded with One #2 Herculine™ Suture 510(K Number Ko42778
Submitter A.
Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908 Registration Number: 1017294
Company Contact B.
Elizabeth Paul Manager, Regulatory Affairs (727) 399-5234 Telephone (727) 399-5264 FAX
C. Device Name
| Trade Name: | BioAnchor® with Disposable Driver,
Preloaded with One #2 Herculine™ Suture |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Suture Anchor |
| Classification Names: | Screw, Fastener Fixation, Biodegradable, Soft tissue; 21 CFR 888.3040. Suture,
Nonabsorbable, Synthetic, Polyethylene; 21 CFR 878.5000 |
| Proposed Class/Device: | Class II |
| Product Code: | MAI, GAT, HWC |
1
page of 2
PROPRIETARY INFORMATION -- LINVATEC CORPORATION
Summary of Safety and Effectiveness
Summary of Sarety and Ellectiveness
BioAnchor® with Disposable Driver, Preloaded with One #2 Herculine™
Suture Suure
510(k) # Ko42778 October 1, 2004
Predicate/Legally Marketed Devices D.
510(k) # K033804 BioAnchor® with Disposable Driver Linvatec Corporation
Device Description E.
The BioAnchor® with Disposable Driver, Preloaded with One #2 The BloAnchor® with Disposable "Diver", "Al-laction -PLLA suture Herculine™ Sulure is an injection moraded with a single strand of the a anchor Implant pre-infeaded while a suture, preloaded onto a absorbable driver with a stainless steel shaft and ABS handle. The disposable driver with a Stamloed store creation with One #2 BloAnchol® - will is supplied sterile and single use.
The modification described in this Special 510(K) is to replace the The modification described in the openal a Herculine™ High Strength polyethylene non-absorbable suture.
This modification does not affect the device's intended use, I his "modification" does" hot "andor" the "here specifications.
fundamental scientific technology or performance specifications.
Intended Use F.
information® with Disposable Driver, Preloaded with One #2 Herculine™ The BloArchol® Will Disposable Briver of the shoulder; specifically,
Suture is intended for soft tissue repair of the shoulder; specifically, Suture is intended for Soft tissue repair thifts and capsulolabral reconstruction.
Substantial Equivalence G.
The BioAnchor® with Disposable Driver, Preloaded with One #2 The BloAnchol® Min Diopoodio Dquivalent in design and intended Herculine … Suture is Substantially equing has been use to the DioAnchor® with Bloging the suture in the device does not conducted to accure transarding safety and effectiveness.
Page 1.3
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" written around it. Inside the circle is a stylized symbol that resembles an abstract eagle or bird with three curved lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 4 2004
Ms. Elizabeth Paul Manager, Regulatory Affairs Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773
Re: K042778
Trade/Device Name: BioAnchor® with Disposable Drive, Preloaded with #2 Herculine™ Suture Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC, MAI Dated: October 1, 2004 Received: October 6, 2004
Dear Ms. Paul:
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. Elizabeth Paul
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 yours.
L. Alvah N. Millikan
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
PROPRIETARY INFORMATION – LINVATEC CORPORATION
Indications for Use
510(k) Number (if known):
Device Name: BioAnchor® with Disposable Driver, Preloaded with One #2 Herculine™ Suture
Indications For Use:
Indications For Sol.
The BioAnchor® with Disposable Driver, Preloaded with One #2 Herculine™ Suture is The BioAnchow with Disposable Diver, i reloaded with Shoulder; specifically, Bankhart and SLAP repair,
intended for soft tissue repair of the shoulder; specifically, Bankhart intended for son tissas report for struction.
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)
Office of Device Evaluation (ODE) Concurrence of CDRH,
Mark A Miller
Division of General, Restorative, and Neurological Devices
510(k) Number K042778 Page 1 of 1