(62 days)
The Surgical Dynamics ' S•D sorb • E-Z Tac' is indicated for use in soft tissue to bone fixation for rotator cuff repairs and reattachment of the glenoid labrum and/or inferior glenohumeral ligament.
The Surgical Dynamics* S.D sorb* E-Z Tac* is an absorbable implant to be used for affixing soft tissue to bone.
This section of the 510(k) lacks specific acceptance criteria and detailed study information that would allow for a complete table of acceptance criteria and device performance, or a comprehensive description of a study proving the device meets acceptance criteria. The provided text is a summary of safety and effectiveness for a medical device (Surgical Dynamics SD sorb E-Z Tac, a bone anchor) and the FDA's clearance letter.
Based on the provided text, here's what can be extracted and what information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this document. The document states that the device is "substantially equivalent" to predicate devices, which implies that it meets certain general safety and effectiveness standards comparable to those predicates. However, specific, quantifiable acceptance criteria (e.g., tensile strength, degradation rate, biocompatibility metrics, clinical success rates) are not detailed here. | Not directly reported in this document. The document does not contain specific test results or clinical outcomes that directly demonstrate performance against quantifiable criteria. It only states that the device is "composed entirely of biocompatible materials which are in compliance with ISO 10993-1 for their intended patient contact profile" and that it is "substantially equivalent" to predicate devices. |
Missing Information:
- Specific numerical or qualitative acceptance criteria for mechanical properties, biocompatibility, degradation, or clinical efficacy.
- Actual test results or performance metrics from any studies.
2. Sample Sizes Used for the Test Set and Data Provenance
This information is not provided in the document. The text does not describe any specific test set for evaluation, nor does it mention sample sizes or data provenance (e.g., country of origin, retrospective/prospective nature of data).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The document primarily focuses on regulatory clearance based on substantial equivalence, not on specific clinical studies involving expert adjudication for ground truth.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
This information is not provided in the document. MRMC studies are typically for imaging or diagnostic devices to assess reader performance with/without AI assistance, which is not relevant to this type of mechanical implant device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not provided and is not applicable. This is a physical, absorbable surgical implant, not a software algorithm.
7. The Type of Ground Truth Used
This information is not explicitly stated as part of a formal "ground truth" establishment for a study in the provided text. The regulatory clearance is based on the device being "substantially equivalent" to predicate devices. This implies that the device design, materials, and intended use are similar enough to already approved devices, which would have had their own evidence of safety and efficacy (their "ground truth" or clinical validity) established prior to their market entry. For this specific 510(k), the "ground truth" for showing safety and effectiveness is implicitly tied to that of the predicate devices and general biocompatibility standards (e.g., ISO 10993-1 compliance).
8. The Sample Size for the Training Set
This information is not provided and is not applicable. This is a physical medical device, not an AI/ML algorithm that would require a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not applicable, as there is no "training set" for this type of device.
Summary of the Study (Based on Provided Text):
The provided document describes a 510(k) Premarket Notification for the Surgical Dynamics* S.D sorb* E-Z Tac* device. This is a regulatory submission process in the U.S. for medical devices.
- Type of Study: This is not a classic "study" in the sense of a clinical trial or performance evaluation with specific acceptance criteria beyond regulatory compliance. Instead, it's a demonstration of "substantial equivalence" to legally marketed predicate devices.
- Purpose: To show that the new device is as safe and effective as existing predicate devices and does not raise new questions of safety and effectiveness.
- Methodology (implied): The submission likely included:
- Comparison to Predicate Devices: Detailed comparison of the device's design, materials, indications for use, and technological characteristics to the predicate devices (Surgical Dynamics* S.D sorb* E-Z Tac* (K961585), Surgical Dynamics* S.D sorb* Suture Anchor (K961578), Mitek GII Bone Anchor (K953877)).
- Biocompatibility Testing: The text explicitly mentions "composed entirely of biocompatible materials which are in compliance with ISO 10993-1 for their intended patient contact profile." This indicates that biocompatibility studies were conducted, likely in accordance with this standard, to ensure the materials are safe for human implantation.
- Mechanical/Performance Testing (implied): While not detailed, a substantial equivalence submission for an implantable device like a bone anchor would typically include non-clinical performance data (e.g., mechanical strength, degradation properties, fixation strength) to show that it performs similarly to the predicate devices and meets design specifications. These tests would be in vitro or ex vivo.
- Outcome: The FDA determined that the device is "substantially equivalent" to the predicate devices, allowing it to be marketed.
In essence, this document is a regulatory approval notice, not a detailed research paper describing a specific performance study with explicit acceptance criteria and results. The "proof" the device meets acceptance criteria comes from its successful comparison to predicate devices, which are already considered safe and effective, and its compliance with general biocompatibility standards.
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K973281 Nov. 3, 1997
Summary of Safety and Effectiveness IX.
United States Surgical Corporation SUBMITTER: 150 Glover Avenue Norwalk, CT 06856
Sharon L. Murphy CONTACT PERSON:
-
August 28, 1997 DATE PREPARED:
Staple, Fixation, Bone CLASSIFICATION NAME: -
Pop Rivet COMMON NAME:
Surgical Dynamics* S.D sorb* E-Z Tac* PROPRIETARY NAME:
Surgical Dynamics* S•D sorb* E-Z Tac* (K961585) PREDICATE DEVICES: Surgical Dynamics* S.D sorb* Suture Anchor (K961578) Mitek GII Bone Anchor (K953877)
- The Surgical Dynamics* S.D sorb* E-Z Tac* is an DEVICE DESCRIPTION: absorbable implant to be used for affixing soft tissue to bone.
- The Surgical Dynamics* S•D sorb* E-Z Tac* is indicated INTENDED USE: for use in soft tissue to bone fixation for rotator cuff repairs and for reattachment of the glenoid labrum and/or inferior glenohumeral ligament.
- Like all the devices manufactured by United States MATERIALS: Surgical Corporation, the Surgical Dynamics* S.D sorb* E-Z Tac* device is composed entirely of biocompatible materials which are in compliance with ISO 10993-1 for their intended patient contact profile.
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Image /page/1/Picture/2 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 3 1997
Ms. Sharon L. Murphy ·Senior Requlatory Affairs Associate United States Surgical Corporation 150 Glover Avenue Norwalk, Connecticut 06856
Re: K973281 Trade Name: Surgical Dynamics* SD sorb E-Z Tac* Requlatory Class: II Product Codes: MAI and JDR Dated: August 28, 1997 Received: September 2, 1997
Dear Ms. Murphy:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 cláss II (Special Controls) or class III (Premarket Approval), 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 895. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Sharon L. Murphy
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Colin M. Witton, Ph.D., M.
Cella M. Witten, 'Ph.D., M.D. Director
Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use IV.
K973281 510(k) Number (if known):
Surgical Dynamics* EZ-Tac* Device Name:
Indications For Use:
indications i or 550.
The Surgical Dynamics ' S•D sorb • E-Z Tac' is indicated for use in soft tissue to bone fixation for rotator cuff repairs and reattachment of the glenoid labrum and/or inferior glenohumeral ligament.
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(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH , Office of Device Evaluation (ODE)
OR Over-The-Counter Prescription Use: _ メ Use:
(Per 21 CFR 801.109)
(Division Sign-Off) Division of General Restorative Device 510(k) Number .
Premarket Notification United States Surgical Corporation * Trademark of United States Surgical Corporation Page 8
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§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.