(49 days)
Not Found
Not Found
No
The summary describes a mechanical fixation device made of titanium with no mention of software, algorithms, or any technology related to AI or ML.
No
Explanation: This device is a fixation staple used in orthopedic procedures to provide soft tissue fixation to bone. Its purpose is to physically attach tissues, not to provide therapeutic treatment or diagnostic information.
No
Explanation: This device is a fixation staple used in orthopedic procedures to provide soft tissue fixation to bone. Its intended use is therapeutic (repair/reconstruction), not diagnostic.
No
The device description clearly states it is a physical staple made from titanium and includes a reusable insertion tool, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used in vitro (outside the body).
- The Intrinsic Therapeutics Fixation Staple is a surgical implant used to fix soft tissue to bone within the human body. It is used in vivo (inside the body).
The description clearly states its intended use is for orthopedic procedures involving fixing tendons and ligaments to bone. This is a direct surgical intervention, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The Intrinsic Therapeutics Fixation Staple is intended for providing soft tissue fixation to bone in orthopedic procedures such as:
-
- Tendon repairs, transfers, or transplants, such as in the treatment of paralytic conditions, tendon avulsions or ruptures, in which the tendon is fixed to the bone.
-
- Ligament repairs, reconstruction, or replacement in which the ligament is fixed to the bone.
Product codes (comma separated list FDA assigned to the subject device)
JDR
Device Description
The Intrinsic Therapeutics Fixation Staple is made from 6Al 4V ELI Titanium conforming to ASTM F136. The legs of the staple have barbs and are curved to provide strength in bone fixation. The staple is provided sterile. A reusable insertion tool is provided to facilitate insertion of the staple.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone
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
Benchtop testing was performed on the Intrinsic Therapeutics Fixation staple and the predicate devices. The Intrinsic Therapeutics Fixation Staple functioned as intended and met the test criteria. Package integrity tests were performed to support the listed shelf life.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Benchtop testing was performed on the Intrinsic Therapeutics Fixation staple and the predicate devices. The Intrinsic Therapeutics Fixation Staple functioned as intended and met the test criteria.
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.
Not Found
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
K071637 Page lot 2
510(k) SUMMARY
Intrinsic Therapeutics Fixation Staple
AUG -- 3 2007
Applicant:
Intrinsic Therapeutics, Inc. 30 Commerce Way Woburn, MA 01801 USA
Phone: (781) 932-0222 Facsimile: (781) 932-0252
Krishna Uppugonduri Contact Person: June 14, 2007 Date Prepared:
Trade Name of Device
Intrinsic Therapeutics Fixation Staple
Common or Usual Name
Fixation Staple
Classification Name
Staple, Fixation, Bone 21 CFR 888.3030, Product Code: JDR
Predicate Devices
(1) Conmed Linvatec Fixation Staple (2) Smith & Nephew Fixation Staple
Intended Use / Indications for Use
The Intrinsic Therapeutics Fixation Staple is intended for providing soft tissue fixation to bone in orthopedic procedures such as:
-
- Tendon repairs, transfers, or transplants, such as in the treatment of paralytic conditions, tendon avulsions or ruptures, in which the tendon is fixed to the bone.
-
- Ligament repairs, reconstruction, or replacement in which the ligament is fixed to the bone.
1
c71637 Page a.t2
Device Description/Technological Characteristics
The Intrinsic Therapeutics Fixation Staple is made from 6Al 4V ELI Titanium conforming to ASTM F136. The legs of the staple have barbs and are curved to provide strength in bone fixation. The staple is provided sterile. A reusable insertion tool is provided to facilitate insertion of the staple.
Performance Data
Benchtop testing was performed on the Intrinsic Therapeutics Fixation staple and the predicate devices. The Intrinsic Therapeutics Fixation Staple functioned as intended and met the test criteria. Package integrity tests were performed to support the listed shelf life.
Substantial Equivalence
The Intrinsic Therapeutics Fixation Staple is as safe and effective as the predicate devices. The Intrinsic Therapeutics Fixation Staple has the same intended use, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the Intrinsic Therapeutics Fixation Staple and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the Intrinsic Therapeutics Fixation Staple is as safe and effective as the predicates. Thus, the Intrinsic Therapeutics Fixation Staple is substantially equivalent.
Conclusions:
Based upon the proposed device's design and technological characteristics, indications for use, and results of comparative testing against predicate devices, the Intrinsic Therapeutics Fixation Staple is considered to be substantially equivalent to the cited legally marketed predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Intrinsic Therapeutics, Inc. % Mr. Krishna Uppugonduri 30 Commerce Way Woburn, MA 01801
AUG - 3 2007
Re: K071637
Trade/Device Name: Intrinsic Therapeutics Fixation Staple Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories. Regulatory Class: II
Product Code: JDR Dated: June 14, 2007 Received: June 15, 2007
Dear Mr. Uppugonduri:
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 - Mr. Krishna Uppugonduri
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 from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark A. Mcllheran
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known):_K071637
Device Name: Intrinsic Therapeutics Fixation Staple
Indications for Use:
The Intrinsic Therapeutics Fixation Staple is intended for providing soft tissue fixation to bone in orthopedic procedures such as:
-
Tendon repairs, transfers, or transplants, such as in the treatment of paralytic conditions, tendon avulsions or ruptures, in which the tendon is fixed to the bone.
-
Ligament repairs, reconstruction, or replacement in which the ligament is fixed to the bone.
Prescription Use _X (Part 21 C.F.R. 801 Subpart D)
AND/OR
Over-The-Counter Use (21 C.F.R. 807 Subpart C)
(QLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
|--|--|
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | K071637 |
|---|---|
| Page | of |
Intrinsic Therapeutics Fixation Staple 510(k) Page 13