(314 days)
Not Found
Not Found
No
The description focuses on the physical properties and intended use of a resorbable surgical staple, with no mention of AI or ML.
Yes
The device is used for the repair of meniscal tears, which is a therapeutic intervention aimed at restoring the function of the meniscus.
No
The device, the Surgical Dynamics™ Meniscal Staple, is used for the repair of tears in the meniscus, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a physical staple made of resorbable material, intended for surgical repair of the meniscus. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the repair of meniscal tears in vivo (within the body). IVDs are used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a physical staple used for tissue approximation. It is implanted into the body. IVDs are typically reagents, instruments, or systems used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information based on laboratory results.
This device is a surgical implant used for a therapeutic purpose, not a diagnostic one.
N/A
Intended Use / Indications for Use
The Surgical Dynamics™ Meniscal Staple** is indicated for the repair of vertical longitudinal full thickness tears (i.e., bucket-handle) in the red-red and red-white zones.
Product codes
MAI
Device Description
The Surgical Dynamics™ Meniscal Staple** consists of a resorbable braid connecting the two resorbable legs of the staple. The staple is used in the approximation of soft tissue, specifically the meniscus. The device is made of a resorbable copolymer, a polyester derivative of lactic and glycolic acids. Polylactic/polyglycolic acid copolymer degrades and resorbs in vivo by hydrolysis into lactic and glycolic acids which are then metabolized by the body.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
meniscus
Indicated Patient Age Range
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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
In vitro and in vivo performance testing demonstrated Surgical Dynamics™ Meniscal Staple is suitable for use in the approximation of meniscal tissue.
Key Metrics
Not Found
Predicate Device(s)
PDS II Suture. Ethicon, Inc.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
96 5228 ARY OF INFORMATION: 510(k) St
NOV 10 1997
- United States Surgical Corporation SUBMITTER: 150 Glover Avenue Norwalk, CT 06856 (203) 845-1000
- Craig M. Audet CONTACT PERSON:
- DATE PREPARED: October 31, 1997
CLASSIFICATION NAME: Fastener, Fixation, Biodegradable Soft Tissue
- Absorbable Implantable Staple COMMON NAME:
Trademark name not yet determined. PROPRIETARY NAME:
PDS II Suture. Ethicon, Inc. PREDICATE DEVICE:
- The Surgical Dynamics™ Meniscal Staple** consists DEVICE DESCRIPTION: of a resorbable braid connecting the two resorbable legs of the staple. The staple is used in the approximation of soft tissue, specifically the meniscus. The device is made of a resorbable copolymer, a polyester derivative of lactic and glycolic acids. Polylactic/polyglycolic acid copolymer degrades and resorbs in vivo by hydrolysis into lactic and glycolic acids which are then metabolized by the body.
- The Surgical Dynamics™ Meniscal Staple** is INTENDED USE: indicated for the repair of vertical longitudinal full thickness tears (i.e., bucket-handle) in the red-red and red-white zones.
- All component materials of the Surgical Dynamics™ MATERIALS: Meniscal Staple** and stapler are comprised of biosafe materials which are in accordance with ISO Standard #10993-1.
PERFORMANCE In vitro and in vivo performance testing demonstrated TESTING: Surgical Dynamics™ Meniscal Staple is suitable for use in the approximation of meniscal tissue.
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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing 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
NOV 10 1997
Mr. Craig M. Audet Director, Corporate Regulatory Affairs United States Surgical Corporation 150 Glover Avenue Norwalk, Connecticut 06856
K965228 Re: Surgical Dynamics™ Meniscal Staple Regulatory Class: II Product Code: MAI Dated: August 11, 1997 Received: August 14, 1997
Dear Mr. Audet:
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, Druq, 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (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 requlations.
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Paqe 2 - Mr. Craig M. Audet
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 requlation (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,
a M. Witten, Ph.D., M.D. Cel Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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II. Indications Page:
| 510(k) Number: | K965228 |
|---|---|
| Device Name: | Surgical Dynamics™ Meniscal Staple** |
| Indications for Use: | The Surgical Dynamics™ Meniscal Staple** is |
| indicated for the repair of vertical longitudinal full | |
| thickness tears (i.e., bucket-handle) in the red-red and | |
| red-white zones. |
(Please do not write below this line - continue on another page if necessary) Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use:
Over-The-Counter Use:
carlefo
(Division Sign-Off)
General Restorative Devices
L965228
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