(86 days)
Not Found
No
The description focuses on the mechanical function of the biopsy kits and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is described as a biopsy tool used to remove tissue for diagnostic purposes, not for treating a condition.
No
The device is a biopsy tool used to remove a sample of bone tissue for diagnostic purposes, it does not perform the diagnostic analysis itself.
No
The device description clearly states it is a "biopsy tool" and "kits," which are physical instruments used to remove tissue samples. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a biopsy tool used to remove a sample of bone tissue from a vertebral body. It is a surgical instrument used on the patient to obtain a specimen.
- Purpose of the Sample: While the sample is taken for "diagnostic purposes," the device itself is the tool for obtaining the sample, not for performing the diagnostic test on the sample. The diagnostic testing would be done separately in a laboratory using IVD devices.
Therefore, the Stryker Bone and Vertebral Body Biopsy Kits are surgical devices used for specimen collection, not IVD devices used for analyzing specimens.
N/A
Intended Use / Indications for Use
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.
Product codes
KNW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Vertebral body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
DEC 1 7 2003
KO32943
Image /page/0/Picture/2 description: The image shows the logo for Stryker Instruments. The word "stryker" is in a bold, sans-serif font on the top line. Below it, the word "INSTRUMENTS" is in a similar font, but slightly smaller and bolder.
4 100 East Mi ham Avenne
Kalumazoo, MI 49001
Phone (200) 323 - 2000
Giosae (2009) 323 - 2000
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510(k) Summary
| Trade Name: | Stryker Bone and Vertebral Body Biopsy Kit and Stryker Capture Bone and
Vertebral 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 Mathis
Vertebral 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. |
| Technological
Comparison: | Stryker's Bone and Vertebral Biopsy Kits are equivalent and
operate similar to the predicate devices listed. |
| Submitted by: | Dannielle C. Wheeler
Regulatory Affairs Representative, Stryker Instruments |
| | 9/19/2003 |
Signature
Date
Date Submitted: 9/19/2003
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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
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.
2
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:
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.
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
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