(55 days)
Not Found
No
The 510(k) summary describes a mechanical suture anchor and inserter, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is described as being used for "rotator cuff repairs," which is a medical intervention aimed at treating a health condition.
No
Explanation: The device description states it is a "suture anchor" intended for "rotator cuff repairs," which is a treatment device, not a diagnostic one. There is no mention of it being used to detect, monitor, or diagnose a condition.
No
The device description clearly states it consists of a suture anchor, suture, cartridge, needles, and a disposable inserter, all of which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "rotator cuff repairs," which is a surgical procedure performed directly on the patient's body. IVDs are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health.
- Device Description: The device is a "suture anchor" made of stainless steel with suture and an inserter. This is a surgical implant and delivery system, not a diagnostic tool used for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples, detecting biomarkers, or providing diagnostic information based on in vitro testing.
Therefore, the Pre-Loaded UltraFix® RC is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Pre-Loaded UltraFix® RC is intended to be used for rotator cuff repairs in the shoulder. The repair technique can be either arthroscopically or in an open technique.
Product codes
MBI
Device Description
The Pre-Loaded UltraFix® RC is supplied sterile and consists of the Pre-Loaded UltraFix® suture anchor with USP#2 non-absorbable polyester suture with cartridge and needles preloaded onto a single disposable inserter. The Pre-Loaded UltraFix® RC is made from 316(L) stainless steel per ASTM F138-92 or ASTM F138-92 and conforms to ISO 5832-1.
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
Performance testing has been conducted to demonstrate safety and effectiveness.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
DEC 1 9 2001
October 23, 2001
SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the requirements of the Safe Medical Device Act of In accordance with the requirements of the Sale Medical Donatting the Market Corporation of the Market Corporation of the Pre-Loaded UltraFix in 20
1990 and 21 CFR 807.92, Linvatec Corporation is nereoy addining of the Pre-Loaded UltraFix®
510(k) Summary of Safety and Effectiveness for the Pre-Loaded UltraFix®
RC. RC.
510(k) Number _K013553.
Submitter A.
Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908
Company Contact B.
Laura D. Seneff, RAC Laurager, Regulatory Affairs (727) 399-5234 Telephone (727) 399-5264 FAX
Device Name C.
Trade Name: Pre-Loaded UltraFix® RC
Common Name: Suture Anchor
Fastener, Fixation, Nondegradable, soft Classification Names: tissue
Proposed Class/Device: Class II, MBI Product Code
1
Summary of Safety and Effectiveness Summary UltraFix® RC Kol3553 510(k) # _ October 23, 2001 Page 2 of 2
Predicate/Legally Marketed Devices
Predicate/Legally Marketed Devices D.
K963812 UltraFix® RC Linvatec
E.
Device Description
The Pre-Loaded UltraFix® RC is supplied sterile and consists of an
the Pre-Loaded UltraFix® with USP#2 non-absorbable polyester The Pre-Loaded UltraFix® RC is supplied stenie and other Hick To suture anchor with USP#2 noreadson onto a single from
suture with cartidge and needles preloaded onto a single from
suture with carting The Bre-Loaded UltraFix® RC is Oltania With carridge and needles preloaded UltraFix® RC is made from
disposable inserter. The Pre-Loaded UltraFix® RC is made from
disposable inserter. The Pre-Loaded UltraF Suture The Fre-Loaded UntraPRS Tre-Loaded UntraPRS TRO-18 The Free States
316(L) stainless steel per ASTM F138-92 or ASTM F138-92 and
316(L) stainless steel per ASTM F138-92 conforms to ISO 5832-1.
r.
Intended Use
The Pre-Loaded UltraFix® RC is intended to be used for rotator cuff
es and the site of be sither arthroscopically or in an open technique. mtendop on
Substantial Equivalence Substantial Equivalence
The Pre-loaded UltraFix® RC is substantially equivalent in design,
The Pre-loaded by total use to Linvateds existing UltraFix® RC G. The Pre-loaded UltraFix® RC is substantially equivalorit works of technology and intended use to Linvated testing has been conducted to
Suture Anchor System. Performance testing has been conduction in toonliness
Suture Anchor System. Performance testing has boon controller in the modeling the modeling the model safety and effectiveness.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an abstract symbol. The symbol resembles an eagle with three stylized lines representing its wings, and a wavy line below, possibly representing water or a ribbon. The logo is printed in black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 9 2001
Ms. Laura Seneff Regulatory Affairs Linvatec 11311 Concept Boulevard Largo, Florida 33773-4908
Re: K013553
K013535
Trade/Device Name: Pre-Loaded UltraFix® RC
Trade/Device Name: Pre-Loaded UltraFix® RC
Coade/Device Name: CAR 2019 2010 Trade/Device rumber: 21 CFR 888.3040 Regulation Number: 21 CFF 888.3040
Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener
T Regulatory Class: Class II Product Code: MBI Dated: October 23, 2001 Received: October 25, 2001
Dear Ms. Seneff:
Dour reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 5 I (K) prematics not incent of the indications
referenced above and have determined the device is substantially equivalent (for the indications referenced above and have determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to legally market device Institute America Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Medical Food, Drug, commerce prior to May 28, 1976, the enactment and of ho received by the Federal Food, Drug,
devices that have been reclassified in accordance with the provisions of the Feder devices that have been reclassified in accordance with the proval online to more of the Act.
and Cosmetic Act (Act) that do not require approval of a premarket approval optiv and Cosmetic Act (Act) that do not require approval or approval or the Act. The
You may, therefore, market the device, subject to the general controls of the Act. The Act You may, therefore, market the device, subject to the general conner provincial controls.
general controls provisions of the Act include requirements for ammanding and general controls provisions of the Act include requirements for allude organism misbranding and adulteration.
at antil is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) into either class in (Special Conaction of the country to comments of the can
may be subject to such additional controls. Existing m may be subject to such additional controls. Existing major regalatown a literation, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. be found in the Code of Federal Regulations, Frito 21, Children
please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA's ssuance of a substanted activals.ited adverseasing of the Act
that FDA has made a determination that your device complies with other requires. that FDA has made a determination that your are complet Federal agencies. You must
or any Federal statutes and regulations soluncian but not limited to: registration and li or any Federal statutes and regulations administed by out a ugestiration and listing (21
comply with all the Act's requirements, including, but not limited to regultents as s comply with all the Act's requirements, including, but not mines were requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements CFR Part 807); labeling (21 CFR Part 801); godd manufacture; pract and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 1f ap forth in the quality systems (QS) regulation (21 CFR Part 22) ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3
Page 2 - Ms. Laura Seneff
This letter will allow you to begin marketing your device as described in your Section 510(k)
I allegally and the TDA Finding of substantial equivalence of your device to a This letter will allow you to begin marketing your device of your device of your device to a legally
premarket notification. The in a cleasification for your device and thus, premarket notification. The FDA finding of substantial equivalite on 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 and If you desire specific advice for your device on our labeling regulation of the Office of
additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the It you are at (201) 594-4659. Additionally, for questions on the promotion and advertising of
Compliance at (301) 594-4659. Additionally, for questions on the promotion and Compliance at (301) 594-4659. Additionally, for questions on and promotes of the one the your device, please contact the Office of Complance at (01) 397 (1) 37 Part 807.97).
regulation entitled, "Misbranding by reference to prematket may be otained from the regulation entitled, "Mishranding by reference to premailer homments" (
Other general information on your responsibilities under the Act may be obtained from the 1984 - 1988 - 1998 - 1998 - 1998 - 1995 - 1995 - 1998 - 1998 - 1998 - 1998 - 1998 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 -Division of Small Mianufacturers, Incat its Internet address
(800) 638-2041 or (301) 443-6597 or at its Internet in . ht (800) 638-2041 or (301) 445-6597 or ar le no no no no no http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Divison of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
cc: HFZ-401 DMC HFZ-404 510(k) Staff HFZ-410 DGRND D.O. D/t: SWFoster:bxw:12/18/01
4
Page 1 of 1
October 23, 2001
510(k) Number (if known): John 3553
Device Name: Pre-Loaded UltraFix® RC
Indications for Use:
The Pre-Loaded UltraFix® RC is intended to be used for rotator cuff repairs in the The FTC-Eoadou Oldar of an open technique.
(Division Sign-Off) Division of Gener Restorative and Neurological ... vices
510(k) Number L
(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE If NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
(Per 21 CFR 801.109)
Over-the-Counter Use_
(Optional Format 1-2-96)