(84 days)
Not Found
No
The 510(k) summary describes a physical suture anchor and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a suture anchor used for reattaching soft tissue, which is a therapeutic intervention aimed at restoring function and healing.
No
The device, the Composite Hitch™ Suture Anchor, is described as being used for soft tissue reattachment procedures and its function involves being screwed or pushed into bone, indicating it is a surgical implant rather than a device for diagnosis.
No
The device description clearly states it is a "soft tissue anchor" made of "composite, resorbable material" and is "preloaded with polyethylene surgical suture," indicating it is a physical implantable device, not software.
Based on the provided information, 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, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Composite Hitch™ Suture Anchor is a physical implantable device used to reattach soft tissue to bone during surgical procedures. It is used in the body, not to test samples from the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, chemical reactions, or diagnostic information derived from bodily fluids or tissues.
The device is a surgical implant used for structural repair, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
Indications for the Composite Hitch™ Suture Anchor include use in soft tissue reattachment procedures in the shoulder, wrist/hand, elbow, and knee. Specific indications are as follows:
Shoulder: Bankart repair, SLAP lesion repair, acromioclavicular separation repair, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair.
Wrist/Hand: Scapholumate linament reconstruction
Elbow: Tennis elbow repair, Biceps tendon reconstruction, medial and lateral repairs, ulhar or radial collateral ligament reconstruction.
Knee: Extracapsular repair: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis, patellar ligament/tendon repair, vastus medialis obliquus (VMO) muscle advancement.
Product codes (comma separated list FDA assigned to the subject device)
JDR, HWC
Device Description
The Composite Hitch™ Suture Anchor is made with a composite, resorbable material. The soft tissue anchor, preloaded with polyethylene surgical suture, enables the implantable anchor by screwing it in through a tapped pre-drilled hole or by simply pushing the point directly into the bone without pre-drilling a starter hole.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, wrist/hand, elbow, and knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicate that the anchors are substantially equivalent to predicate anchors with similar indications for use.
Clinical Testing: None provided as a basis for substantial equivalence.
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
K081172 page 174
Image /page/0/Picture/1 description: The image shows the logo for BIOMET MANUFACTURING CORP. The logo is in a simple, sans-serif font. The word "BIOMET" is in a larger font than the words "MANUFACTURING CORP."
510(k) Summarv
JUL 1 7 2008
Preparation Date: April 22, 2008
Applicant/Sponsor: Biomet Sports Medicine, Inc. (formerly known as Arthrotek, Inc.)
Contact Person: Becky Earl
Proprietary Name: Composite Hitch™ Suture Anchor
Common Name: Suture anchor
Classification Name: Fastener, fixation, biodegradable, soft tissue (21 CFR 888,3030)
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
- Hitch™LactoSorb® Suture Anchor, K061657, Biomet, Inc. �
- Soft Tissue Screw and Washer, K012572, Biomet, Inc. �
- t Biocryl Rapide Bioknotless BR Anchor, K070925, DePuy Mitek
Device Description:
The Composite Hitch™ Suture Anchor is made with a composite, resorbable material. The soft tissue anchor, preloaded with polyethylene surgical suture, enables the implantable anchor by screwing it in through a tapped pre-drilled hole or by simply pushing the point directly into the bone without pre-drilling a starter hole.
Intended Use:
Indications for the Composite Hitch™ Suture Anchor include use in soft tissue reattachment procedures in the shoulder, wrist/hand, elbow, and knee. Specific indications are as follows:
Shoulder: Bankart repair, SLAP lesion repair, acromioclavicular separation repair, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair.
Wrist/Hand: Scapholunate ligament reconstruction
Elbow: Tennis elbow repair, Biceps tendon reconstruction, medial and lateral repairs, ulnar or radial collateral ligament reconstruction.
Knee: Extracapsular repair: Medial collateral ligament repair, lateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis, patellar ligament/tendon repair, vastus medialis obliquus (VMO) muscle advancement.
Summary of Technologies: The Composite Hitch™ Suture Anchor has similar or identical technological characteristics (design, materials, and functional performance) as the predicate devices.
Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicate that the anchors are substantially equivalent to predicate anchors with similar indications for use.
Clinical Testing: None provided as a basis for substantial equivalence.
All trademarks are property of Biomet Inc.
3 21 30 3 3 13 15 5 22 201 304 552 Attored BE MOST 1430 我去下载的主要的意义的意见 Clices 122 1411 1 4 14 Hon Par 1 1 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 ສາມາ ອື່ນ ການປະກວດ
Shipping address 9.923 Dat Cars
5 - 1
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. To the left of the eagle is a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 7 2008
Biomet Manufacturing Corp. % Ms. Becky Earl Regulatory Affairs Specialist P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K081172 Trade/Device Name: Composite Hitch™ Suture Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: JDR, HWC Dated: April 22, 2008 Received: April 24, 2008
Dear Ms. Earl:
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.
2
Page 2 - Ms. Becky Earl
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 yours,
Mark N. Millican
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):____________________________________________________________________________________________________________________________________________________
Device Name: Composite Hitch™ Suture Anchor
Indications for Use:
Indications for the Composite Hitch™ Suture Anchor include use in soft tissue reattachment procedures in the shoulder, wrist/hand, elbow, and knee. Specific indications are as follows:
Shoulder: Bankart repair, SLAP lesion repair, acromioclavicular separation repair, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair.
Wrist/Hand: Scapholumate linament reconstruction
Elbow: Tennis elbow repair, Biceps tendon reconstruction, medial and lateral repairs, ulhar or radial collateral ligament reconstruction.
Knee: Extracapsular repair: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis, patellar ligament/tendon repair, vastus medialis obliquus (VMO) muscle advancement.
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ NO (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Вавеневир
Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number_k081172