(43 days)
Not Found
No
The device description focuses on a mechanical instrument for suture placement and does not mention any computational or data-driven components indicative of AI/ML.
No
The device is used to close the sternum after surgery by passing sutures through it; it is not described as having any therapeutic effect on the patient's condition or disease.
No
The device is described as a sternum closure device used during surgery to hold and close the sternum after a sternotomy, indicating it is an interventional or therapeutic device, not a diagnostic one.
No
The device description clearly outlines multiple hardware components: a reusable instrument, a single-use disposable cartridge, a single-use disposable needle, and sutures. It describes a mechanical process for driving a needle through the sternum. There is no mention of software as a component or primary function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The FASTCLOSE Sternum Closure Device is a surgical instrument used during surgery to physically close the sternum with sutures. It does not analyze biological samples or provide diagnostic information.
- Intended Use: The intended use is to "hold and close the sternum after a sternotomy" and "aid in the prevention of suture needlestick injuries." This is a mechanical/surgical function, not a diagnostic one.
The device is a surgical tool used for a procedural purpose, not for analyzing biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The FASTCLOSE Sternum Closure Device is intended for use during thoracic surgery to hold and close the sternum after a sternotomy. It is designed to aid in the prevention of suture needlestick injuries.
Product codes
GAQ
Device Description
The FASTCLOSE Sternum Closure Device has four major components: 1) a reusable instrument, 2) a single-use, disposable cartridge, 3) a single-use, disposable needle, and 4) sutures.
The cartridge containing the needle (with suture attached) is loaded onto the distal end of the device. The needle is engaged by the device's internal drive mechanism and driven through the sternum to be sutured. The suture is thus passed completely through the wound. Once the suture is in place, the device is withdrawn from the incision leaving the suture strand looped through the sternum. Additional interrupted stitches are place in the same manner and then the two ends of each suture are tied together in the usual fashion.
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
thoracic surgery
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
Bench testing was performed to demonstrate that the FASTCLOSE Sternum Closure Device would perform as intended.
Key Metrics
Not Found
Predicate Device(s)
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
SEP 2 3 2003
K032468 P1/2
FASTCLOSE™ Sternum Closure Device
SuturTek Incorporated 510(k) Premarket Notification
510(k) Summary of Safety and Effectiveness SuturTek FASTCLOSE Sternum Closure Device August 8, 2003
Sponsor Name Sponsor/Manufacturer: SuturTek Incorporated 51 Middlesex Street North Chelmsford, Massachusetts 01863 Telephone: 978-251-8088 FAX: 978-251-8585
2. Device Name
Proprietary Name: FASTCLOSE™ Sternum Closure Device
Common/Usual Name: Suture, Nonabsorbable, Steel, Monofilament And Multifilament
Panel: General Surgery Product Code: GAQ 878.4495 - Suture, Nonabsorbable, Steel, Monofilament And Multifilament
- Identification of Predicate or Legally Marketed Device 3. SuturTek FASTCLOSE Fascia Closure Device K011105 SuturTek FASTCLOSE Fascia Closure Device K030227 Aesculap Steelex Sternum Set K023411
Device Description র্বা
The FASTCLOSE Sternum Closure Device has four major components: 1) a reusable instrument, 2) a single-use, disposable cartridge, 3) a single-use, disposable needle, and 4) sutures.
The cartridge containing the needle (with suture attached) is loaded onto the distal end of the device. The needle is engaged by the device's internal drive mechanism and driven through the sternum to be sutured. The suture is thus passed completely through the wound. Once the suture is in place, the device is withdrawn from the incision leaving the suture strand looped through the sternum. Additional interrupted stitches are place in the same manner and then the two ends of each suture are tied together in the usual fashion.
1
KO32468$_{B2/2}$
SuturTek Incorporated 510(k) Premarket Notification FASTCLOSE™ Sternum Closure Device
న్. Intended Use
The FASTCLOSE Sternum Closure Device is intended for use during thoracic surgery to hold and close the sternum after a sternotomy.
It is designed to aid in the prevention of suture needlestick injuries.
- Comparison of Technological Characteristics 6.
The FASTCLOSE Sternum Closure Device is substantially equivalent in its intended use and/or function to the following predicate devices:
SuturTek FASTCLOSE Fascia Closure Device K011105 SuturTek FASTCLOSE Fascia Closure Device K030227 Aesculap Steelex Sternum Set K023411
The operating principle, materials, intended use and design of construction of the FASTCLOSE Sternum Closure Device is the same as that of the predicate devices: a manual instrument is used to pass stainless steel needles through sternum for fixation with stainless steel sutures.
- 7 Performance Testing
Bench testing was performed to demonstrate that the FASTCLOSE Sternum Closure Device would perform as intended.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined strands. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus. The seal is black and white.
Public Health Service
SEP 2 3 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SuturTek, Inc. c/o Ms. Debbie lampietro ORC Consulting 7 Tiffany Trail Hopkinton, Massachusetts 01748
Re: K032468
Trade/Device Name: FASTCLOSE Sternum Closure Device Regulation Number: 21 CFR 878.4495 Regulation Name: Stainless steel suture Regulatory Class: II Product Code: GAQ Dated: August 8, 2003 Received: August 19, 2003
Dear Ms. Iampietro:
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
Page 2 - Ms. Debbie Iampietro
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) 594-4659. 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 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.
iriam C. Provost
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
SuturTek Incorporated 510(k) Premarket Notification FASTCLOSE™ Sternum Closure Device
K032Y68
510(k) Number (if known):
FASTCLOSE Sternum Closure Device Device Name:
Indications For Use:
The FASTCLOSE Sternum Closure Device is intended for use during thoracic surgery to hold and close the sternum after a sternotomy. It is designed to aid in the prevention of suture needlestick injuries.
(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 _________________________________________________________________________________________________________________________________________________________
Miriam C. Provoost
Division of General, Restorative and Neurological Device
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510(k) Number K032468