(66 days)
The SuturTek Surgical Steel Suture is intended for use in sternal closure.
The SuturTek Surgical Steel Suture is a sterile, single-use, non absorbable, stainless steel monofilament suture. It is designed to remain inside the patient. It may or may not be attached to a stainless steel needle. The needle and any unused portions of suture are disposables.
The provided text describes a 510(k) summary for a surgical steel suture and does not contain detailed information about acceptance criteria, device performance, or a study proving its conformance beyond general bench testing. The document is primarily focused on demonstrating substantial equivalence to predicate devices for regulatory approval.
Therefore, many of the requested details cannot be extracted from the given input.
Here's a breakdown of what can be inferred or directly stated from the provided text, and what is missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated. The document mentions "Bench testing was performed to demonstrate that the SuturTek Surgical Steel Suture would perform as intended." without listing specific performance metrics or thresholds.
- Reported Device Performance: Not explicitly stated. The document indicates that bench testing was performed and implies successful performance ("would perform as intended"), but no quantitative results are provided.
2. Sample sized used for the test set and the data provenance
- Sample Size for Test Set: Not mentioned.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not mentioned. It's bench testing, so "country of origin" of data wouldn't typically apply in the same way as clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable as the testing described is bench testing, not a clinical study involving expert interpretation or ground truth establishment in a diagnostic sense.
4. Adjudication method for the test set
- Not applicable as the testing described is bench testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, a MRMC comparative effectiveness study was not done. The device is a surgical suture, not an AI or imaging diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. The device is a surgical suture, not an algorithm.
7. The type of ground truth used
- Not applicable in the conventional sense. For bench testing of a physical device, the "ground truth" would be the engineering specifications and performance standards against which the device is tested. These specifics are not detailed in the provided text.
8. The sample size for the training set
- Not applicable, as this is a physical medical device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not applicable, as this is a physical medical device.
Summary of available information:
- Study Type: Bench testing.
- Purpose of Study: To demonstrate that the SuturTek Surgical Steel Suture would perform as intended.
- Conclusion of Study (implied): The bench testing was successful, as the FDA granted 510(k) clearance based on substantial equivalence.
- Device Intended Use: For use in sternal closure during thoracic surgery.
- Comparison Basis: Substantial equivalence to predicate devices (Aesculap: Steelex Sternum Set; K023411 and CP Medical: Surgical Steel Monofilament Stainless Steel; K030351). The operating principle, materials, intended use, and design of construction are stated to be the same as predicate devices.
Missing Information (critical for your request): Detailed acceptance criteria, specific performance results, sample sizes, and expert involvement (as the study was bench testing).
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510(k) Summary of Safety and Effectiveness SuturTek Surgical Steel Suture December 1, 2006
FEB 7 2007
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- Sponsor Name Sponsor/Manufacturer: SuturTek Incorporated 51 Middlesex Street North Chelmsford, Massachusetts 01863 Telephone: 978-251-8088 FAX: 978-251-8585
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- Contact person: A. Arthur Rankis 508 847-5961
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- Device Name Proprietary Name: SuturTek Surgical Steel Suture
Common/Usual Name: Surgical Suture, Nonabsorbable, Stainless Steel.
Panel: General and Plastic Surgery Devices Panel Product Code: GAQ 878.4495 - Suture, Nonabsorbable, Steel, Monofilament And Multifilament
5. Device Description
The SuturTek Surgical Steel Suture is for use during thoracic surgery to hold and close the sternum after a sternotomy (i.e. for use in sternal closure).
The SuturTek Surgical Steel Suture is a sterile, single-use, non absorbable, stainless steel monofilament suture. It is designed to remain inside the patient. It may or may not be attached to a stainless steel needle. The needle and any unused portions of suture are disposables.
- Intended Use 6.
The SuturTek Surgical Steel Suture is intended for use in sternal closure.
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- Comparison of Technological Characteristics 7.
The SuturTek Surgical Steel Suture is substantially equivalent in its intended use and/or function to the following predicate devices:
Aesculap: Steelex Sternum Set; K023411 CP Medical: Surgical Steel Monofilament Stainless Steel; K030351
The operating principle, materials, intended use and design of construction of the SuturTek Surgical Steel Suture 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.
8. Performance Testing
Bench testing was performed to demonstrate that the SuturTek Surgical Steel Suture would perform as intended.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized eagle-like symbol with three curved lines representing the body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SuturTek Incorporated % A. A. Rankis & Associates Mr. A. Arthur Rankis President 6 Brookside Circle Acton, Massachusetts 01720
FEB 7 2007
Re: K063603
Trade/Device Name: SuturTek Surgical Steel Suture Regulation Number: 21 CFR 878.4495 Regulation Name: Stainless steel suture Regulatory Class: II Product Code: GAQ Dated: December 1, 2006 Received: December 5, 2006
Dear Mr. Rankis:
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
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Page 2 - Mr. A. Arthur Rankis
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.
-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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html .
Sincerely yours,
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SuturTek Incorporated 510(k) Premarket Notification
SuturTek Surgical Steel Suture
િન્વ ભડ્તાના નિર્માન કારણે તાલુકામાં આવેલું એક ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપા
510(k) Number (if known):
Device Name:
SuturTek Surgical Steel Suture
Indications For Use:
The SuturTek Surgical Steel Suture is intended for use in sternal closure.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of &DRH, Office of Device Evaluation (ODE)
(Division Sign-Off) (Division of General, Restorative, and Neurological Devices
510(k) Number
Page 1 of
§ 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.