(28 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and fixation strength of a resorbable rivet, with no mention of AI or ML technology.
Yes
The device is used for soft tissue reattachment in shoulder procedures to facilitate healing, which aligns with the definition of a therapeutic device.
No
Explanation: The device description indicates it is a resorbable rivet designed for soft tissue reattachment during surgical procedures, not for identifying or diagnosing a medical condition.
No
The device description clearly states it is a physical, resorbable rivet made of Lactosorb® Copolymer, designed for surgical implantation. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided information clearly describes a surgical implant (resorbable rivets) used for soft tissue reattachment during shoulder procedures. This is a direct surgical intervention on the body, not an examination of a specimen outside the body.
The device's function is mechanical fixation within the body, which is the opposite of an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
These devices are indicated for soft tissue reattachment in the following shoulder procedures:
- Instability repairs in the shoulder (Bankart Procedures)
- SLAP lesion repair
- Acromio-clavicular separation repairs
- Rotator cuff tear repairs
- Capsular shift or capsulolabral reconstructions
- Biceps tenodesis
- Deltoid repairs
Product codes (comma separated list FDA assigned to the subject device)
HRS, JDR, MAI
Device Description
Cannulated Arthrorivet™ and Cannulated RC Arthrorivet™ are resorbable rivets made of Lactosorb® Copolymer. They are designed with ribbed legs that extend during actuation to hold the rivets in the desired position. The heads incorporate spikes to grip the soft tissue and hold it in place during the healing process.
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 Testing: Mechanical testing indicated equivalent or greater fixation strength of the Cannulated Arthrorivet™ and the Cannulated RC Arthrorivet™ compared to the predicate device.
Clinical Testing: No clinical testing was necessary for determination of 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
DEC - 5 2003
Kc33519 Pge 194
BIOMET
510(k) Summary
| Applicant/Sponsor: | Arthrotek Inc.
(A wholly owned subsidiary of Biomet Inc.)
56 East Bell Drive
P.O. Box 587
Warsaw, IN 46581-0587
FDA Registration #: 1825034 |
| -------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
- Gary Baker Contact Person: 56 East Bell Drive P.O. Box 587 Warsaw, IN 46581-0587 Telephone: (574) 372-1568 Fax: (574) 372-1683
- Cannulated Arthrorivet™ and Cannulated RC Arthrorivet™ Proprietary Name:
- Resorbable Pop Rivet Common Name:
- Fastener, Fixation, Biodegradable, Soft Tissue Classification Name:
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
Lactosorb® Pop Rivet - 510(k) K981798 cleared on July 13, 1998.
- Cannulated Arthrorivet™ and Cannulated RC Arthrorivet™ are resorbable Device Description: rivets made of Lactosorb® Copolymer. They are designed with ribbed legs that extend during actuation to hold the rivets in the desired position. The heads incorporate spikes to grip the soft tissue and hold it in place during the healing process.
MAILING ADDRESS P:O. Box 587 Warsaw, IN 46581-0587
발
SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582
1
571 206.2742
79
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| Indications for Use: | These devices are indicated for soft tissue reattachment in the following shoulder procedures: |
|---|---|
| 1. Instability repairs in the shoulder (Bankart Procedures) | |
| 2. SLAP lesion repair | |
| 3. Acromio-clavicular separation repairs | |
| 4. Rotator cuff tear repairs | |
| 5. Capsular shift or capsulolabral reconstructions | |
| 6. Biceps tenodesis | |
| 7. Deltoid repairs | |
| Summary of Technologies: | Cannulated Arthrorivet TM and Cannulated RC Arthrorivet TM are manufactured from the same materials and utilizing the same manufacturing practices as the predicate devices. |
| Non-Clinical Testing: | Mechanical testing indicated equivalent or greater fixation strength of the Cannulated Arthrorivet TM and the Cannulated RC Arthrorivet TM compared to the predicate device. |
| Clinical Testing: | No clinical testing was necessary for determination of substantial equivalence. |
:
:
All trademarks are property of Biomet, Inc.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three swooping lines representing its wings. The eagle is positioned to the right of 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
DEC = 5 2003
Mr. Gary Baker Regulatory Specialist Biomet, Inc. P.O. Box 587 Warsaw, Indiana 46581
Re: K033519
Trade/Device Name: Cannulated Arthronvet™ and Cannnulated RC Arthronvet™ Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple component Metallic Bonc Fixation Appliances and Accessories Regulatory Class: Class II Product Code: HRS, JDR, MAI Dated: November 5, 2003 Received: November 7, 2003
Dear Mr. Baker:
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 accordunce 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
3
Page 2 - Mr. Gary Baker
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. 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 (301) 594-4639. 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,
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
Statement of Indications For Use
510(k) Number (IF KNOWN): _ K ω {} } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } }
Device Name: Cannulated Arthrorivet™ and Cannulated RC Arthrorivet™
Indications for Use: These devices are indicated for soft tissue reattachment in the following shoulder procedures:
-
- Instability repairs in the shoulder (Bankart Procedures)
- SLAP lesion repair 2.
- Acromio-clavicular separation repairs 3.
- Rotator cuff tear repairs 4.
-
- Capsular shift or capsulolabral reconstructions
-
- Biceps tenodesis
-
- Deltoid repairs
(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 (Optional Format 1-2-96) | No |
Division Sign-Off
Division of Ge , Restorative
and Neurologi Devices
510(k) Number K033519