(53 days)
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Not Found
No
The device description focuses solely on the material composition and intended use of a bioresorbable rivet for soft tissue reattachment. There is no mention of any software, algorithms, or data processing capabilities that would indicate the presence of AI or ML.
No
The device is a bioresorbable implant used for soft tissue reattachment during surgical procedures, which is generally considered a surgical aid rather than a therapeutic device that treats disease or medical condition.
No
Explanation: This device is described as a surgical implant for soft tissue reattachment, not for diagnosing conditions.
No
The device description explicitly states it is composed of bioresorbable and biocompatible polymers, indicating it is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical device used for soft tissue reattachment in various shoulder procedures. This is an in-vivo application (within the living body).
- Device Description: The description details the composition and mechanism of a bioresorbable implant used within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the living body) to analyze biological samples. This device is used in vivo as a surgical implant.
N/A
Intended Use / Indications for Use
The LactoSorb®Pop Rivet are indicated for use in soft tissue reattachment in the following shoulder procedures:
-
- instability repairs in the shoulder (Bankart procedures)
-
- SLAP lesion repair
-
- Acromio-clavicular separation repairs
-
- Rotator cuff repairs
-
- Capsular shift or capsulolabral reconstructions
-
- Biceps tenodesis
-
- Deltoid repair
Product codes (comma separated list FDA assigned to the subject device)
87HWC, JDR, MAI, HRX
Device Description
The LactoSorb* Pop Rivets are composed of bioresorbable and biocompatible polymers that have been used in surgical procedures for years. LactoSorb* resorbable copolymer is a synthetic polyester derived from lactic and glycolic acids. Polylactic/polyglycolic acid copolymer degrades and resorb IN VIVO by hydrolysis to lactic and glycolic acids which are then metabolized by the body. In animal studies LactoSorb* has been found to be biocompatible in both soft tissue and bone tissue.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
shoulder
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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.
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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.
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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).
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§ 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.
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JUL 1 3 1998
510(K) SUMMMARY OF SAFETY AND EFF
SUBMITTER: Biomet, Inc. Airport Industrial Park P. O. Box 587 Warsaw IN 46580 -0587
Contact Person: Julie K. Ryan
ﺎ ﻳﻮﺟﺪ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪ Product Code: 87HWC .
Device Name: LactoSorb® Pop Rivet
The LactoSorb®Pop Rivet are indicated for use in soft tissue reattachment in the following shoulder procedures:
-
- instability repairs in the shoulder (Bankart procedures)
-
- SLAP lesion repair
-
- Acromio-clavicular separation repairs
-
- Rotator cuff repairs
-
- Capsular shift or capsulolabral reconstructions
-
- Biceps tenodesis
-
- Deltoid repair
ﻢ ﺍﻟﻤﺤﺎﻓﻈﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ
The LactoSorb* Pop Rivets are composed of bioresorbable and biocompatible polymers that have been used in surgical procedures for years. LactoSorb* resorbable copolymer is a synthetic polyester derived from lactic and glycolic acids. Polylactic/polyglycolic acid copolymer degrades and resorbs IN VIVO by hydrolysis to lactic and glycolic acids which are then metabolized by the body. In animal studies LactoSorb* has been found to be biocompatible in both soft tissue and bone tissue.
The use of this device in the shoulder indications listed above does not raise any new types of safety and effectiveness when compared to the predicate device.
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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 3 1998
Ms. Julie K. Ryan ·Requlatory Specialist Biomet, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587
Re : K981798 LactoSorb® Pop Rivet Requlatory Class: II Product Codes: JDR, MAI, and HRX Dated: May 20, 1998 May 21, 1998 Received:
Dear Ms. Ryan:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. ਸੈ substantially equivalent determination assumes compliance with ... _ the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Ms. Julie K. Ryan
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Col. M. Whitten, Ph.D.
Ph.D., M.D. M. Witten, Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) NUMBER (IF KNOWN): K981798
LactoSorb* Pop Rivet DEVICE NAME:
INDICATIONS FOR USE:
The LactoSorb* Pop Rivets are indicated for use in soft tissue reattachment in the following procedures:
- instability repairs in the shoulder (Bankart Procedures) 1 . .
- SLAP lesion repair 2.
- 3 . . Acromio-clavicular separation repairs
- Rotator cuff tear repairsg 4. - 4.
- Capsular shift or capsuloral reconstructions 5.
- 6 . Biceps Tenodesis
- 7 :- Deltood repairs
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X OR Over-The-Counter-Use
(Per 21 CFR 801.109) (Optional Format 1-2-96)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K981798 |
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