(41 days)
K#931271
K#931271
No
The device description and performance studies focus on the material properties and sterilization of a surgical wire, with no mention of AI or ML.
No.
The Stena-Wire is used to close and hold the sternum after surgery, serving as a mechanical support rather than directly treating a disease or condition. Its function is to approximate and stabilize tissues, which is a surgical aid, not a therapeutic action in itself.
No
The device description clearly states its purpose as a surgical suture used to close and hold the sternum after a median sternotomy, which is a therapeutic function rather than a diagnostic one.
No
The device description clearly states it is a physical surgical wire and needle made of stainless steel, intended for sternal closure. It 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 medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Sterna-Wire Function: The Sterna-Wire is a surgical implant used within the body to physically close and hold the sternum after surgery. It does not analyze or test any biological specimens.
The description clearly states its use in thoracic surgery for sternal closure, which is a surgical procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Stony Brook Surgical Innovations' (SBSI) Sterna-Wire is a non-absorbable Stainless Steel Wire with an attached needle that is used during thoracic surgery to close and hold the sternum after a median sternotomy. The Sterna-Wire remains in the Sternum indefinitely and is not removed.
Product codes
GAQ
Device Description
Sterna-Wire is indicated for use in the Sternal Closure. Sterna-Wire is a non absorbable sterile surgical suture composed of 316L stainless steel. The wire material consists of 18" (45cm) 316L stainless steel surgical suture wire and the needle material is a 420 stainless steel sharp semi-circular needle, sterile, nonabsorbable, single use. The product will be packaged as 2 wires, 2 sterna-band and 4 wires, 4 sterna-band and 2 wires, and 2 sterna-band products.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Sternum
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
Discussion of Non-Clinical Tests Performed for Determination of 7. Substantial Equivalence are as follows:
- USP 21 Stainless Steel Suture Monographs, Modified -
- ASTM F899 Standard Designations -
- AAMI/ANSI/ISO 11137 ETO Sterilization Requirements -
Discussion of Clinical Tests Performed: 8.
Not Applicable
Key Metrics
Not Found
Predicate Device(s)
K#931271
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4495 Stainless steel suture.
(a)
Identification. A stainless steel suture is a needled or unneedled nonabsorbable surgical suture composed of 316L stainless steel, in USP sizes 12-0 through 10, or a substantially equivalent stainless steel suture, intended for use in abdominal wound closure, intestinal anastomosis, hernia repair, and sternal closure.(b)
Classification. Class II (special controls). The device, when it is a steel monofilament suture that is uncoated and does not incorporate barbs, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9. The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.
0
EXHIBIT #1
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is: K0\30;59
1. Submitter's Identification:
Stony Brook Surgical Innovations ("SBSI") 25 Asharoken Avenue Northport, NY 11768
Contact: Mr. Marc Leahy
Date Summary Prepared: August 23, 2001
2. Name of the Device:
Stony Brook Surgical Innovations Sterna-Wire (Sternal Sutures)
3. Predicate Device Information:
Ethi-Pack™ Surgical Stainless Steel Suture. Ethicon, Inc., Somerville, NJ, K#931271
4. Device Description:
Sterna-Wire is indicated for use in the Sternal Closure. Sterna-Wire is a non absorbable sterile surgical suture composed of 316L stainless steel. The wire material consists of 18" (45cm) 316L stainless steel surgical suture wire and the needle material is a 420 stainless steel sharp semi-circular needle, sterile, nonabsorbable, single use. The product will be packaged as 2 wires, 2 sterna-band and 4 wires, 4 sterna-band and 2 wires, and 2 sterna-band products.
5. Intended Use:
The Stony Brook Surgical Innovations' (SBSI) Sterna-Wire is a non-absorbable Stainless Steel Wire with an attached needle that is used during thoracic surgery to close and hold the sternum after a median sternotomy. The Sterna-Wire remains in the Sternum indefinitely and is not removed.
1
Comparison to Predicate Devices: e.
The wire material (18" 316L Stainless Steel Wire) and the needle material (420 Stainless Steel Sharp Semi Circular Needle) are identical between subject and predicate devices. Packaging for both devices consists of cardboard sleeve and tyvek pouch. Sterilization for both devices is by ETO and intended use for both devices is median stenotomy closure. The Ethipak device is packaged in 2, 4 and 6 units, whereas the subject device is packaged in 2 units per package or 2, 4/1 units with the Sterna-Band product.
Discussion of Non-Clinical Tests Performed for Determination of 7. Substantial Equivalence are as follows:
- USP 21 Stainless Steel Suture Monographs, Modified -
- ASTM F899 Standard Designations -
- AAMI/ANSI/ISO 11137 ETO Sterilization Requirements -
Discussion of Clinical Tests Performed: 8.
Not Applicable
9. Conclusions:
The subject device, Stony Brook Surgical Innovations Sterna-Wire, has the same intended use and characteristics as the predicate device, the Ethi-Pack™ Surgical Stainless Steel Suture. Moreover, bench testing contained in our submission and non-clinical testing supplied demonstrates that there are no differences in their technological characteristics, thereby not raising any new questions of safety or effectiveness. Thus, the Stony Brook Surgical Innovations Sterna-Wire is substantially equivalent to the predicate device, the Ethi-Pack™ Surgical Stainless Steel Suture.
2
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of an eagle.
OCT 2 2 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Stony Brook Surgical Innovations c/o Ms. Susan D. Goldstein-Falk MDI Consultants, Inc. 55 Northern Boulevard, Suite 200 Great Neck, New York 11021
Re: K013059
Trade/Device Name: Sterna-Wire Regulation Number: 21 CFR 878.4495 Regulation Name: Stainless steel suture Regulatory Class: Class II Product Codes: GAQ Dated: September 7, 2001 Received: September 11, 2001
Dear Ms. Goldstein-Falk:
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.
3
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 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 your device, 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). 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,
Susan Walky wo
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
Exhibit B
Page _ 1 __ of __ 1 __
510(k) Number (if known): K013059
Device Name: Stony Brook Surgical Innovations ("SBSI") Sterna-Wire
Indications For Use:
The Stony Brook Surgical Innovations' (SBSI) Sterna-Wire is a non-absorbable The Otony Brook Ourgreal Innevached needle that is used during thoracy surgery Otaliness Stool Will of the stemum after a median sternotomy. The Sterna-Wire remains in the Sternum indefinitely and is not removed.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use (Optional Format 1-2-96)
(Division Sign-Off)
(Division Sign-OII)
Division of General, Restorative
Division of General Devices Division of General, and Neurological Devices
Neurologi
510(k) Number K013059