(90 days)
The DePuy DuPont Absorbable Set Screw is intended to provide early fixation of the bone block in bone-patellar-tendon-bone graft in anterior cruciate ligament reconstruction.
The DePuy DuPont Absorbable Set Screw is a fully threaded, cannulated, headless cancellous bone screw with a blunt tip. It is manufactured from poly-L-lactic acid (PLLA) and is available in a 9.0mm diameter in seven lengths (20, 25, 30, 35, 40, 45, and 50mm). The screw is inserted by a square headed drive which is broached into the minor diameter of the screw body. The screw is used to compress the bone block against the wall of the bone tunnel and secure the ACL graft. The screw is gradually resorbed by the body.
This document (K972494) is a 510(k) premarket notification for a medical device and does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and study design.
Specifically, this submission grants clearance based on the device's substantial equivalence to previously marketed devices, rather than requiring extensive clinical studies with specified acceptance criteria and performance metrics as would be found in a Premarket Approval (PMA) application or a more comprehensive de novo submission.
Therefore, many of the requested data points (such as acceptance criteria, reported performance values, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and detailed ground truth establishment) are not typically included or required in a 510(k) submission based on substantial equivalence.
Here's what can be inferred or stated based on the provided document:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as quantifiable performance metrics for this 510(k) submission. The primary "acceptance criterion" for a 510(k) is demonstrating substantial equivalence to a predicate device.
- Reported Device Performance: No specific quantitative performance data (e.g., strength, resorption rate) is reported for the DePuy DuPont Absorbable Set Screw in this document. The document primarily focuses on describing the device and comparing its characteristics to predicate devices.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- No "test set" in the context of a performance study with human or animal subjects is described. The substantial equivalence determination is based on a comparison of device design, materials, and intended use.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable as there is no described test set requiring expert ground truth establishment for performance evaluation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable.
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:
- Not applicable. This device is a surgical implant, not an AI-powered diagnostic tool. MRMC studies are not relevant to its clearance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate devices. The DePuy DuPont Absorbable Set Screw demonstrates substantial equivalence by sharing the "same principles of graft fixation" and similar design/material characteristics with these predicate devices.
8. The sample size for the training set:
- Not applicable. There is no training set in the context of an algorithm.
9. How the ground truth for the training set was established:
- Not applicable.
Summary based on the document:
This 510(k) clearance is based on demonstrating substantial equivalence to existing, legally marketed predicate devices. The primary arguments for equivalence are:
- Intended Use: All devices (DePuy DuPont Absorbable Set Screw and predicates) are intended for "early fixation of the bone block in bone-patellar-tendon-bone graft in anterior cruciate ligament (ACL) reconstruction."
- Principles of Operation: They "employ the same principles of graft fixation."
- Technological Characteristics: Comparisons are made regarding design (fully threaded, cannulated, headless, blunt/pointed/tapered tip), dimensions (9.0mm diameter, various lengths), and materials (PLLA for the proposed device and Hyloc; titanium for others). Specific mention is made that the DePuy DuPont Absorbable Set Screw and the Hyloc Interference Screw are manufactured from PLLA with the "same specifications and obtained from the same supplier."
The FDA's review concludes that the device is substantially equivalent, and therefore, it is considered safe and effective for its stated indications for use under the general controls provisions of the Act. No specific performance study with quantifiable acceptance criteria or detailed clinical outcome data is presented in this 510(k) summary.
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SUMMARY OF SAFETY AND EFFECTIVENESS
NAME OF FIRM:
DePuy, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
FIRM CONTACT:
Sally Foust Clinical Affairs Associate (219) 372-7455 FAX (219) 267-7098 e-mail: Sally Foust(@ccgate.depuy.com
TRADE NAME: COMMON NAME: CLASSIFICATION: DEVICE PRODUCT CODE:
DePuy DuPont Absorbable Set Screw Bone/Tendon/Bone Screw 888.3040 Smooth or threaded bone fixation fastener 87 HWQ
SUBSTANTIALLY EQUIVALENT DEVICES: Hyloc™ Interference Screw (DePuy DuPont) DePuy Set Screw M. Kurosaka Interference Screw (DePuy) DePuy Advantage Fixation Screw System
DEVICE DESCRIPTION AND INTENDED USE: The DePuy DuPont Absorbable Set Screw is a fully threaded, cannulated, headless cancellous bone screw with a blunt tip. It is manufactured from poly-L-lactic acid (PLLA) and is available in a 9.0mm diameter in seven lengths (20, 25, 30, 35, 40, 45, and 50mm).
The DePuy DuPont Absorbable Set Screw is intended to provide early fixation of the bone block in bone-patellar-tendon-bone graft in anterior cruciate ligament (ACL) reconstruction. The screw is inserted by a square headed drive which is broached into the minor diameter of the screw body. The screw is used to compress the bone block against the wall of the bone tunnel and secure the ACL graft. The screw is gradually resorbed by the body.
BASIS OF SUBSTANTIAL EQUIVALENCE: The DePuy DuPont Absorbable Set Screw, Hyloc Interference Screw, DePuy Set Screw, M. Kurosaka Interference Screw, and the DePuy Advantage Fixation Screw System are all intended to provide early fixation of the bone block in bone-patellar-tendon-bone graft fixation in anterior cruciate ligament (ACL) reconstruction, and employ the same principles of graft fixation. All of the substantially equivalent devices are fully threaded, cannulated, headless designs available in a diameter of 9mm. The DePuy DuPont Absorbable Set Screw and the Hyloc Interference Screw are both manufactured from poly-Llactic acid (PLLA) with the same specifications and obtained from the same supplier, and are implanted with a square driver, while the DePuy Set Screw, M. Kurosaka Interference Screw, and the DePuy Advantage Fixation Screw System are manufactured from titanium and are implanted with a hex driver. The DePuy DuPont Absorbable Set Screw, the Hyloc Interference Screw, and the DePuy Set Screw all have a blunt tip, while the M. Kurosaka Interference Screw has a pointed tip and the DePuy Advantage Fixation Screw System has a tapered tip. The DePuy DuPont Absorbable Set Screw, the Advantage Interference Screw and the DePuy Set Screw have the same thread form and pitch. The DePuv DuPont Absorbable Set Screw and the DePuy Set Screw are available in exactly the same lengths (20, 25, 30, 35, 40, 45, and 50mm).
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 1 1997
:
Ms. Sally Foust Clinical Affairs Associate DePuy, Inc. 700 Orthopaedic Drive P.O. Box 988 Warsaw, Indiana 46581-0988
Re: K972494 DePuy DuPont Absorbable Set Screw Regulatory Class: II Product Code: HWC Dated: July 2, 1997 Received: July 3, 1997
Dear Ms. Foust:
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 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. Note that labeling or otherwise promoting a device for pedicular screw fixation/attachment would cause the device to be adulterated under 501(f)(1) of This device, if intended for use in pedicular screw the Act. fixation/attachment, would be found not substantially equivalent and would be a class III device under Section 513 (f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing. Accordingly:
- The package insert must prominently state that the device 1. is intended for the specific use(s) described in the enclosure only; and
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Page 2 - Ms. Sally Foust
You may not label or in any way promote this device for 2 . pedicular screw attachment to, or fixation of the cervical, thoracic or lumbar vertebral column. If this device is a screw with outer diameters of 3 mm - 10 mm and overall lengths of 10 mm - 75 mm inclusively, the package insert must include the following statement, This device is not approved for screw "WARNING: attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine." Any pedicular screw fixation/attachment to the cervical, thoracic or lumbar vertebral column of this device is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulations under 21 CFR, Part 812. All users of the device for pedicular screw fixation/attachment must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) prior to conduct of the investigation.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਕੈ 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 regulation (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 In addition, FDA may publish further announcements action. 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 Requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market.
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Page 3 - Ms. Sally Foust
If you desire specific advice for your device on our labeling II you debire bpos. Bart 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
the regulation entitled, "Misbranding by reference to information on your responsibilities under the Act may be Information of Je Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at at its coll free namber (o://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
~ Celia 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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510(k) Number (if known)长ኖሯ249년
Device Name DePuy DuPont Absorbable Set Screw
Indications for Use:
The DePuy DuPont Absorbable Set Screw is intended to provide early fixation of the bone block in bone-patellar-tendon-bone graft in anterior cruciate ligament reconstruction.
Concurrence of CDRH, Office of Device Evaluation
| Prescription Use X | OR Over-The-Counter Use |
|---|---|
| (Per 21 CFR 801.109) |
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | Rr 72494 |
|---|---|
| --------------- | ---------- |
000002
N/A