The Phantom SofThread Soft Tissue Interference Screw is intended to be used to provide interference fixation of soft tissue grafts in ACL reconstruction.

Device Description

AI/ML Overview

The provided text describes a Special 510(k) Device Modification Premarket Notification for the Phantom™ SofThread Soft Tissue Interference Screw. This type of submission is for minor changes to an already cleared device, and thus, typically relies on demonstrating substantial equivalence to the predicate device rather than conducting extensive new clinical studies with detailed acceptance criteria and performance data as might be found in an original PMA or De Novo submission.

Therefore, many of the requested elements for a study proving device acceptance criteria are not applicable to this specific submission.

Here's a breakdown of the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the traditional sense for a Special 510(k). This submission focuses on demonstrating that minor design modifications to the Phantom SofThread Soft Tissue Interference Screw do not raise new questions of safety and effectiveness compared to the predicate device (K980440).
The "acceptance criteria" here are implicitly tied to maintaining substantial equivalence in terms of:
- Intended Use: Unchanged (interference fixation of soft tissue grafts in ACL reconstruction).
- Materials: Identical.
- Fundamental Scientific Technology: Unchanged.
- Performance (implied): The minor design changes (rounded head, increased broach depth, nose diameter, minor diameter, slightly reduced thread pitch) are presented as not altering the fundamental performance characteristics of the screw in its intended application. The Special 510(k) process assumes that these minor modifications do not necessitate new performance benchmarks or testing beyond what was established for the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. No specific test set data is provided or referenced, as the basis for substantial equivalence is the similarity to the predicate device and conformance with design control procedures, not new clinical performance data from a specific test set.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. No clinical study involving expert-established ground truth is described.

4. Adjudication Method for the Test Set

Not applicable. No test set or related adjudication method is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This type of study is not mentioned or implied. The submission is not comparing the modified device's performance against human readers or other devices in a clinical or diagnostic context.

6. Standalone Performance Study (Algorithm Only)

No. The device is a physical medical implant (interference screw), not an algorithm or AI-driven system.

7. Type of Ground Truth Used

Not applicable. No ground truth, in the context of clinical studies or diagnostic accuracy, is relevant to this Special 510(k). The "ground truth" for this submission is the established safety and effectiveness of the predicate device.

8. Sample Size for the Training Set

Not applicable. This pertains to algorithm development. The device is a physical implant.

9. How the Ground Truth for the Training Set Was Established

Not applicable. (See point 8).

Summary of the Basis for Substantial Equivalence (as provided in the document):

Predicate Device: Phantom SofThread Soft Tissue Interference Screw (K980440)
Key Arguments for Equivalence:
- Unchanged Fundamental Scientific Technology: The basic principle of the screw remains the same.
- Identical Intended Use: Provides interference fixation of soft tissue grafts in ACL reconstruction.
- Identical Materials: No change in the material composition.
- Minor Design Modifications: Rounded head, increased broach depth, nose diameter and minor diameter, and slightly reduced thread pitch. These are considered minor and not impacting the safety or effectiveness to a degree that would necessitate new extensive testing.
- Conformance with Design Control Procedures: Compliance with 21 CFR 820.30 (Quality System Regulation).

Conclusion:

The provided document describes a Special 510(k) submission for a device modification. This pathway is designed for minor changes to an already cleared device. The "acceptance criteria" here are effectively met by demonstrating that the modified device remains substantially equivalent to its predicate device and that the minor changes do not introduce new safety or effectiveness concerns. Therefore, the detailed study information regarding test sets, expert ground truth, and statistical performance metrics typically found in original device approvals is absent and not required for this type of submission.

Summary

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AUG 3 | 1998

SPECIAL 510(k) DEVICE MODIFICATION PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS

NAME OF SPONSOR:	DePuy®, Inc.P.O. Box 988Warsaw, Indiana 46581-0988
510(k) CONTACT:	Sally FoustSenior Regulatory Submissions AssociateDePuy Orthopaedics, Inc.1 (219) 372-7455; FAX: 1 (219) 267-7098E-Mail: Sally_Foust@ccgate.depuy.com
TRADE NAME:	Phantom™ SofThread Soft Tissue Interference Screw
COMMON NAME:	Interference Screw
CLASSIFICATION:	888.3040 - Smooth or threaded bone fixation fastener
DEVICE PRODUCT CODE:	87 HWC

SUBSTANTIALLY EQUIVALENT DEVICE:

Phantom SofThread Soft Tissue Interference Screw (K980440)

DEVICE DESCRIPTION AND INTENDED USE:

The modified Phantom SofThread Screw is a resorbable, cannulated, interference screw with widely spaced, rounded threads and a conical tip, designed for use with soft tissue grafts. The SofThread Screw is available in four diameters (7, 8, 9 and 10mm) in one 25mm length. The modified Phantom SofThread Screw is intended to be used to provide interference fixation of soft tissue grafts in ACL reconstruction.

BASIS OF SUBSTANTIAL EQUIVALENCE:

The fundamental scientific technology of the modified Phantom SofThread Screw has not changed from the FDA cleared (K980440) Phantom SofThread Screw. The intended use of the modified Phantom SofThread Screw as described in its labeling has not changed from the FDA cleared (K980440) Phantom SofThread Screw. With the exception of minor design modifications (i.e., rounded head; increased broach depth, nose diameter and minor diameter, and slightly reduced thread pitch) the modified Phantom SofThread Screw is identical to the FDA cleared (K980440) Phantom SofThread Screw.

Based on conformance with the design control procedures requirements as specified in 21 CFR 820.30, similarities of design, identical materials and intended use, DePuy believes that the modified Phantom SofThread Screw is substantially equivalent to the FDA cleared K980440) Phantom SofThread Screw.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 31 1998

Ms. Sally Foust Senior Requlatory Submissions Associate DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedics Drive 46581-0988 Warsaw, Indiana

Re: K982900 Phantom™ SoftThread Soft Trade Name: Tissue Interference Screw Regulatory Class: II Product Codes: MAI and HWC Dated: August 14, 1998 August 17, 1998 Received:

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 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 class 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. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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 regulations.

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Page 2 - Ms. Sally Foust

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 regulation (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 ene regaration onestica, "MisFidian" (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,

Ph.D., M.D. ia M. Witten, Cel 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) ८ ९ 2

Device Name: Phantom SofThread Soft Tissue Interference Screw

Indications for Use:

The Phantom SofThread Soft Tissue Interference Screw is intended to be used to provide interference fixation of soft tissue grafts in ACL reconstruction.

8/27/98

Concurrence of CDRH, Office of Device Evaluation

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(Division Sign-Off)

Division of General Restorative Devices 510(k) Number .

Prescription Use_ OR X (Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

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Regulation Number and Section

§ 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.