(69 days)
The Steelex Sternum Set is indicated in abdominal surgery, for orthopedic procedures (tendon operations and cerclages), hernia surgery and sternal closure. It is designed to remain inside the patient.
The Steelex Sternum Set consists of a corrosion resistant steel monofilament suture with a specially designed HRS needle for the sternum closure. The set consists of a combination of 2 or 4 steel wite monofilaments armed with a tapercut round bodied needle fixed or rotating. The wire for Steelex Sternum Set is made of stainless steel 316L (ASTMF138) and the needle is made of stainless steel 302, 420 or 420F (ASTMF899). The needle sizes for Steelex Sternum Set are available in the USP sizes 3, 4, 5, 6 and 7.
The provided text is a 510(k) summary for the Steelex Sternum Set, a medical device. It describes the device, its intended use, and its substantial equivalence to other legally marketed devices. However, it does not contain information about acceptance criteria, detailed study designs, or performance metrics in a way that would allow for a comprehensive answer to your request.
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The document mentions "All required testing per USP for Steelex Sternum Set were completed." This implies compliance with USP standards, which would have performance criteria, but they are not detailed here. | "Biomechanical testing results demonstrate the Steelex Sternum Set is substantially equivalent to other suture systems currently on the market." |
Missing Information:
- Specific quantitative acceptance criteria (e.g., tensile strength, knot security, degradation rates).
- The exact numerical performance results of the Steelex Sternum Set against those criteria.
2. Sample size used for the test set and the data provenance
Missing Information: The document does not specify the sample size used for the biomechanical testing mentioned, nor does it provide information on data provenance (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Missing Information: This information is not relevant to this type of device submission. The "ground truth" for a surgical suture would typically be defined by established material science and biomechanical standards, not expert consensus on interpretations.
4. Adjudication method for the test set
Missing Information: Not applicable to this type of device or study.
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
Missing Information: This is not applicable. The Steelex Sternum Set is a surgical suture, not an AI-powered diagnostic or assistive device where MRMC studies with human readers would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Missing Information: Not applicable for this device.
7. The type of ground truth used
- Type of Ground Truth: Established industry standards (USP - United States Pharmacopeia) for surgical sutures and performance of legally marketed predicate devices.
8. The sample size for the training set
Missing Information: This is not applicable for this type of device. There isn't a "training set" in the context of material performance testing for a suture.
9. How the ground truth for the training set was established
Missing Information: Not applicable for this type of device.
Summary of Study Information Provided in the Document:
- Study Purpose: To demonstrate substantial equivalence of the Steelex Sternum Set to predicate devices.
- Study Type: Biomechanical testing.
- Methodology: "All required testing per USP for Steelex Sternum Set were completed." (Implies adherence to USP standards for surgical sutures).
- Performance Outcome: "Biomechanical testing results demonstrate the Steelex Sternum Set is substantially equivalent to other suture systems currently on the market."
- Predicate Devices:
The document is a regulatory summary focused on demonstrating equivalence for market clearance, rather than a detailed scientific publication of a specific study with all the granular details about acceptance criteria and sample sizes. The "performance data" section is very brief, stating that USP testing was completed and biomechanical testing showed substantial equivalence.
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VIII. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS [Accordance with SMDA of 1990]
Steelex Sternum Set
October 10, 2002
DEC 1 9 2002
Aesculap®, Inc. COMPANY: 3773 Corporate Parkwav Center Valley, PA 18034
Establishment Registration Number: 2916714
CONTACT: Georg Keller 800-258-1946 x 5073 (phone) 610-791-6882 (fax)
- TRADE NAME: Steelex Sternum Set
COMMON NAME: Stainless Steel Suture
DEVICE CLASS: Class II
PRODUCT CODE: 79GAQ
CLASSIFICATION: 878.4495 - Suture, Nonabsorbable, Steel, Monofilament And Multifilament
REVIEW PANEL: General and Plastic Surgery
INDICATIONS FOR USE
The Steelex Sternum Set is indicated in abdominal surgery, for orthopedic procedures (tendon operations and cerclages), hernia surgery and sternal closure. It is designed to remain inside the patient.
DEVICE DESCRIPTION
The Steelex Sternum Set consists of a corrosion resistant steel monofilament suture with a specially designed HRS needle for the sternum closure. The set consists of a combination of 2 or 4 steel wite monofilaments armed with a tapercut round bodied needle fixed or rotating. The wire for Steelex Sternum Set is made of stainless steel 316L (ASTMF138) and the needle is made of stainless steel 302, 420 or 420F (ASTMF899). The needle sizes for Steelex Sternum Set are available in the USP sizes 3, 4, 5, 6 and 7,
PURPOSE FOR SUBMISSION
This submission seeks marketing clearance for Aesculap's Steelex Sternum Set.
PERFORMANCE DATA
All required testing per USP for Steelex Sternum Set were completed Biomechanical testing results demonstrate the Steelex Sternum Set is substantially equivalent to other suture systems currently on the market.
SUBSTANTIAL EQUIVALENCE
Aesculap®, Inc. believes that the Steelex Sternum Set is substantially equivalent to:
- Ethicon, Inc. Ethi-Pack Surgical Stainless Steel Suture (K931271) .
- Stony Brook Surgical Innovations Sterna-Wire (K013059) ●
- CardioThoracic Systems, Inc. Acier Sutures (K991073) .
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Georg Keller Regulatory Affairs Manager Aesculap, Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K023411 · Steelex Sternum Set Regulation Number: 878.4495 Regulation Name: Stainless steel suture Regulatory Class: II Product Code: GAQ Dated: October 10, 2002 Received: October 11, 2002
Dear Mr. Keller:
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. Iisting 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 mav 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.
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Page 2 - Mr. Georg Keller
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 vour 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.
Muriam C' Puritz
AW 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
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510(K) Premarket Notifica
B. INDICATIONS FOR USE STATEMENT
Page 1 of 1
510(k) Number:
Device Name:
Steelex Sternum Set
Indication for Use:
The Steelex Sternum Set is indicated in abdominal surgery, for orthopedia procedures (tendon operations and cerclages), hernia surgery and sternal closure. It is designed to remain inside the patient.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use or Over-the-Counter Use (per 21 CFR 801.109)
Muriàm C. Provost
Restorative
§ 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.