(18 days)
Not Found
Not Found
No
The summary describes a physical implantable device for surgical repair and makes no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is described as an implantable staple intended for the repair of meniscal tears, which is a therapeutic intervention.
No
The device is described as an absorbable implantable staple intended for the repair of meniscal tears, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is an "absorbable implantable staple," which is a physical hardware 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, or tissue) to provide information about a person's health.
- Device Description: The Surgical Dynamics Meniscal Staple is an implantable staple used for the repair of meniscal tears. It is a physical device that is surgically placed within the body.
- Intended Use: The intended use is for surgical repair of a specific anatomical structure (the meniscus).
There is no indication that this device is used to analyze biological samples outside of the body. It is a therapeutic device used directly on the patient's tissue.
N/A
Intended Use / Indications for Use
The Surgical Dynamics Meniscal Staple is intended for the repair of vertical longitudinal full thickness tears (i.e., bucket-handle) in the red-red and red-white zones.
Product codes
HWC
Device Description
The currently marketed Surgical Dynamics Meniscal Staple is an absorbable implantable staple. The staple consists of two rigid resorbable barbed legs connected by a length of resorbable, flexible braided filament. The staple is designed to facilitate meniscal repair in the vascular zone of the meniscus.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
meniscus
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)
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.
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
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Attachment 4
DEC 1 1 2001
K 013890
page 1 of 1
510(k) Summary
Surgical Dynamics Meniscal Staple
United States Surgical 150 Glover Avenue Norwalk, CT 06856 USA
DEVICE DESCRIPTION
The currently marketed Surgical Dynamics Meniscal Staple is an absorbable implantable staple The ourtency martides bolymer. The staple consists of two rigid resorbable barbed legs connected by a length of resorbable, flexible braided filament. The staple is designed to facilitate meniscal repair in the vascular zone of the meniscus.
INDICATIONS FOR USE
The Surgical Dynamics Meniscal Staple is intended for the repair of vertical longitudinal full thickness tears (i.e., bucket-handle) in the red-red and red-white zones.
SUBSTANTIAL EQUIVALENCE*
The modified Surgical Dynamics Meniscal Staple was claimed to be substantially equivalent* to the currently marketed version of the device. Information pertaining to this device was provided in the submission.
- Any claim of substantial equivalence is made exclusively in regard to the U.S. Food, Drug and Cosmetic Act and should not be viewed in any other light.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 1 2001
Ms. Jenny Schuck Regulatory Affairs Senior Associate United States Surgical 150 Glover Avenue Norwalk, Connecticut 06856
Re: K013890
Device Name: Surgical Dynamics Meniscal Staple Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: November 20, 2001 Received: November 23, 2001
Dear Ms. Schuck:
We have reviewed your Section 510(k) premarket notification of intent to market the device wo nove 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 for use sured in the encreated 776, the enactment date of the Medical Device Amendments, or to conniner of the 11th 2011-11-11 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 I ou may, alcrever, mains 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 If your device is elassinod (600 as controls. Existing major regulations affecting your device can may or bayer to been 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 r 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 or uny 1 sattail 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 Of It in the quality systems (21 (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. Jenny Schuck
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and my of your finding of substantial equivalence of your device to a legally premarked noutheater - 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 21 CFR Part 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 Compliance alease 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). Other general information on your responsibilities under the Act may be obtained from the Division Other general 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 vours,
Sincerely yours,
Mark A. Melkerson
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
3
Attachment 2
page lof 1
Indications for Use Statement
510(k) Number
Device Name Surgical Dynamics Meniscal Staple
Indications For Use
The Surgical Dynamics Meniscal Staple is intended for the repair of vertical longitudinal full thickness The Durglour Dyl-handle) in the red-red and red-white zones.
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Labels | Values |
|---|---|
| Prescription Use: | Yes |
| (Per 21 CFR 801.109) | |
| OR Over-The-Counter Use: | No |
for Mark N. Melker
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
| Labels | Values |
|---|---|
| 510(k) Number | K013890 |