STRYKER VERTEBRAL BODY AND BONE BIOPSY KITS, STRYKER CAPTURE BODY AND BONE BIOSPSY KITS by STRYKER CORP.

Stryker's Capture Vertebral Body and Bone Biopsy Kits can be used as a stand alone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using a coring, cutting or aspiration technique. The Stryker Capture Bone and Vertebral Body Biopsy Kit and Kit with Guidewire is used to remove a sample of bone tissue from a vertebral body for diagnostic purposes, as well as to provide and maintain access to the same surgical site.

Device Description

Stryker's Bone and Vertebral Body Biopsy Kits can be used as a biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using a coring, cutting or aspiration technique.
Stryker's Capture Vertebral Body and Bone Biopsy Kits can be used as a stand-alone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using a coring, cutting or aspiration technique. The Stryker Capture Bone and Vertebral Body Biopsy Kit and Kit with Guidewire is used to remove a sample of bone tissue from a vertebral body for diagnostic purposes, as well as to provide and maintain access to the same surgical site.

AI/ML Overview

This document is a 510(k) summary for the Stryker Bone and Vertebral Body Biopsy Kit and Stryker Capture Bone and Vertebral Body Biopsy Kit. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than reporting on specific clinical study performance against acceptance criteria.

Therefore, this document does not contain the detailed information necessary to answer most of your questions regarding acceptance criteria and a study proving the device meets them. The 510(k) process for this type of device (Class II, biopsy instrument) often relies on comparisons to legally marketed predicate devices and bench testing to demonstrate safety and effectiveness, rather than extensive clinical efficacy studies with predefined acceptance criteria.

Here's what can be inferred or stated based on the provided text:

A table of acceptance criteria and the reported device performance:
- Not provided. The document states "Stryker's Bone and Vertebral Biopsy Kits are equivalent and operate similar to the predicate devices listed." This is the core "performance" claim for a 510(k) submission, indicating similarity to existing devices, not specific quantitative performance against acceptance criteria.
Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not provided. The document does not mention any specific clinical or performance testing involving a "test set" in the context of human data. It's likely that any testing performed for this 510(k) was bench testing, not clinical human studies.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. No clinical test set with associated ground truth established by experts is described.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. No clinical test set and adjudication process is described.
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 biopsy kit, not an AI-powered diagnostic tool for human readers. Therefore, an MRMC study related to AI assistance would not be relevant.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical instrument (biopsy kit), not an algorithm. Standalone performance as an algorithm is not relevant.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable/Not provided. No clinical studies requiring ground truth are described. For a biopsy device, the ultimate "ground truth" would be the success of obtaining a diagnostic sample leading to accurate pathological diagnosis, but this is not reported in this 510(k) summary. The "ground truth" for showing equivalence would be compliance with recognized standards or comparison to predicate device specifications.
The sample size for the training set:
- Not applicable/Not provided. No AI model training or associated training set is mentioned.
How the ground truth for the training set was established:
- Not applicable/Not provided. No AI model training or associated ground truth establishment is mentioned.

In summary: This 510(k) document is concerned with demonstrating substantial equivalence of a medical device (biopsy kit) to existing predicate devices, not with presenting results from a clinical study against specific performance acceptance criteria typically seen for novel diagnostic algorithms or therapies. The "study" referenced would have been primarily engineering and bench testing to show the device functions similarly to its predicates.

Summary

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DEC 1 7 2003

KO32943

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510(k) Summary

Trade Name:	Stryker Bone and Vertebral Body Biopsy Kit and Stryker Capture Bone andVertebral Body Biopsy Kit
Common Name:	Vertebral Bone Biopsy Needles
Classification Name:	876.1075 Gastroenterology-Urology Biopsy Instruments
Equivalent to:	Parallax Clearview Plus Bone and Vertebral Biopsy Needles (K022169),Parallax Bone and Vertebral Body Biopsy Needles (K011206), IMS MathisVertebral and Bone Biopsy System (K990515)
Device Description:	Stryker's Bone and Vertebral Body Biopsy Kits can be used as a biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using a coring, cutting or aspiration technique.Stryker's Capture Vertebral Body and Bone Biopsy Kits can be used as a stand-alone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using a coring, cutting or aspiration technique. The Stryker Capture Bone and Vertebral Body Biopsy Kit and Kit with Guidewire is used to remove a sample of bone tissue from a vertebral body for diagnostic purposes, as well as to provide and maintain access to the same surgical site.
TechnologicalComparison:	Stryker's Bone and Vertebral Biopsy Kits are equivalent andoperate similar to the predicate devices listed.
Submitted by:	Dannielle C. WheelerRegulatory Affairs Representative, Stryker Instruments
	9/19/2003

Signature

Date

Date Submitted: 9/19/2003

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DEC 17 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Danielle C. Wheeler Regulatory Affairs Representative Stryker Corporation Stryker Instruments Division 4100 E. Milham Avenue Kalamazoo, Michigan 49001

Re: K032943

Trade/Device Name: Stryker Bone and Vertebral Body Biopsy Kit and Stryker Capture Vertebral Body and Bone Biopsy Kit Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology-urology biopsy instrument Regulatory Class: II Product Code: KNW Dated: September 18, 2003 Received: September 23, 2003

Dear Ms. Wheeler:

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 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 - Ms. Danielle C. Wheeler

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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost

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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Indications for Use

510(k) Number: K032943

Device Name: Stryker Bone and Vertebral Body Biopsy Kit and Stryker Capture Vertebral Body and Bone Biopsy Kit

Indications For Use:

Prescription Use X (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 CDRH, Office of Device Evaluation (ODE)

iriam C. Provost

vision Sign-Off) Division of General, Restorative and Neurological Devices

710(k) Number K032943

Page 1 of 1

Regulation Number and Section

§ 876.1075 Gastroenterology-urology biopsy instrument.

(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.