(73 days)
Not Found
No
The summary describes a mechanical bone biopsy kit and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device is clearly indicated as a "biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes," not for treating a disease or condition.
Yes
The device is described as a "biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes." This explicitly states its use in diagnostics.
No
The device description clearly states it is a physical kit consisting of a coaxial biopsy needle, obturator, and syringe, and is used with access cannula and stylet accessories. This indicates it is a hardware device, not software-only.
Based on the provided information, the Stryker IVAS Bone Biopsy Kit is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body for the purpose of providing information for the diagnosis, treatment, or prevention of disease. This examination is performed outside of the living body (in vitro).
- Device Function: The Stryker IVAS Bone Biopsy Kit is a tool used to obtain a sample of bone tissue from the vertebral body. It is a surgical instrument used within the body (in vivo) to collect the specimen.
- Intended Use: The intended use is to "remove a sample of bone tissue... for diagnostic purposes." While the sample will be used for diagnosis, the device itself is the tool for collecting the sample, not for performing the diagnostic test on the sample.
The diagnostic testing on the bone tissue sample would be performed separately in a laboratory, likely using IVD devices or other laboratory methods. The Stryker IVAS Bone Biopsy Kit is the means of obtaining the specimen for those subsequent diagnostic tests.
N/A
Intended Use / Indications for Use
The Stryker IVAS Bone Biopsy Kit 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.
Product codes (comma separated list FDA assigned to the subject device)
KNW
Device Description
The Stryker® iVAS® 8 gauge bone biopsy kit is a disposable device, intended for single-use, individually packaged and provided sterile. The biopsy device will be sold in a kit consisting of a coaxial biopsy needle, obturator and syringe. The biopsy kit is used with access cannula and stylet accessories of compatible size. The access cannula and stylet are sold separately and are Class I exempt under 21 CFR 888.4200, product code OAR (Injector, vertebroplasty (does not contain cement).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
Anatomical Site
Bone and vertebral body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
A risk Management File (RMF), in compliance with EN ISO 14971:2012, Medical devices - Application of risk management to medical devices, was completed to assess the impact of the subject device modification. In accordance with the risk assessment, verification and validation testing was performed in an effort to mitigate risk where possible. Testing performed includes: functional, packaging integrity and sterilization testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Impact testing: Biopsy needle to withstand impact loads of at least 25 cycles at 2-in-lb.
Tensile force testing: Biopsy needle and obturator to withstand a force measuring less than 15-lbs.
Non-axial torque testing: Biopsy needle handle to withstand a force measuring less than 25-in-lb.
Axial torque testing: Biopsy needle handle to withstand a force measuring less than 3.25-in-lb.
Functional testing: Non-swaged biopsy needle must retain an equivalent or greater average subjective size measurement than the swaged biopsy needle.
Sterilization testing: Sterilization method is VDmax25, in compliance with the ISO 11137-1 and ISO11137-2 standards, acceptance criteria includes: Bioburden less than 1000 CFU Less than 2 positive tests of sterility in product verification dose experiment SAL 10-6
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three faces in profile, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 4, 2014
Stryker Instruments Ms. Brittney M. Larsen Senior Regulatory Affairs Representative 4100 E. Milham Avenue Kalamazoo, Michigan 49001
Re: K141673
Trade/Device Name: Stryker iVAS 8 Gauge Bone Biopsy Kit Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology-biopsy instrument Regulatory Class: Class II Product Code: KNW Dated: July 7, 2014 Received: August 8, 2014
Dear Ms. Larsen:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
for
Sincerely yours,
David Krause -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S.
Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K141673
Device Name Stryker® iVAS® 8 Gauge Bone Biopsy Kit
Indications for Use (Describe)
The Stryker IVAS Bone Biopsy Kit 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.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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4100 E. Milham Avenue Kalamazoo, MI 49001
t: 269 323 7700 f: 269 324 5412 www.stryker.com
Image /page/3/Picture/1 description: The image shows the Stryker Instruments logo. The word "stryker" is in bold, sans-serif font, with a registered trademark symbol to the right. Below the word "stryker" is a horizontal line, and below that is the word "Instruments" in a smaller, sans-serif font.
510(k) Summary
I. Contact Details
| a. | 510(k) Owner: | Stryker Instruments
4100 E. Milham Avenue
Kalamazoo, Michigan 49001
USA
Ph: +1-269-323-7700
Fax: +1-269-324-5412 |
|-----|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| b. | FDA Establishment
Registration Number: | 1811755 |
| c. | Contact Person: | Brittney M. Larsen
Ph: +1-269-389-5293
Fax: +1-269-389-5412
Brittney.Larsen@Stryker.com |
| d. | Date Submitted: | June 20, 2014 |
| II. | Device Name | |
| a. | Trade Name: | Stryker® iVAS® 8 Gauge Bone Biopsy Kit |
| b. | Common Name: | Vertebral Bone Biopsy Needles |
| c. | Classification
Name: | Gastroenterology-urology biopsy instrument
(21 CFR 876.1075, Product code KNW) |
| d. | Classification: | II |
III. Legally Marketed Predicate Device(s)
| 510(k) Number | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| K032943 | KNW | Stryker Bone and Vertebral | |
| Body Biopsy Kit | Stryker | ||
| Instruments |
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Image /page/4/Picture/0 description: The image shows the logo for Stryker Instruments. The word "stryker" is in bold, sans-serif font, with a registered trademark symbol to the right of the word. Below the word "stryker" is a horizontal line, and below that is the word "Instruments" in a smaller, sans-serif font.
4100 E. Milham Avenue Kalamazoo. MI 49001 t: 269 323 7700 f: 269 324 5412 www.stryker.com
-Purpose of the Special 510(k) Submission
Stryker submits this Special 510(k): Device Modification to request clearance for a modification to our Stryker Bone and Vertebral Body Biopsy Kit(s). The predicate device(s) are currently cleared for 10-13gauge (G) sizes. The subject modification is to add an 8-G size product offering. which is outside the currently cleared size range. This device modification does not change the intended use, indications for use or the fundamental scientific technology of the predicate device(s).
II. Device Description
The Stryker® Inflatable Vertebral Augmentation System (iVAS®) 8 Gauge Bone Biopsy Kit mav 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.
The Stryker® iVAS® 8 qauge bone biopsy kit is a disposable device, intended for single-use, individually packaged and provided sterile. The biopsy device will be sold in a kit consisting of a coaxial biopsy needle, obturator and syringe. The biopsy kit is used with access cannula and stylet accessories of compatible size. The access cannula and stylet are sold separately and are Class I exempt under 21 CFR 888.4200, product code OAR (Injector, vertebroplasty (does not contain cement).
III. Indications for use
The Stryker iVAS Bone Biopsy Kit 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.
IV. Substantial Equivalence Comparison
The Stryker® iVAS® 8 Gauge Bone Biopsy Kit is substantially equivalent to the Stryker Bone and Vertebral Body Biopsy Kit predicate device(s) (K032943). Stryker claims this equivalence because the Stryker® iVAS® 8 Gauge Bone Biopsy Kit has an equivalent intended use, mechanism for use, and mode of action as compared to the predicate device(s). The differences between the Stryker® iVAS® 8 Gauge Bone Biopsy Kit and the predicate device(s) have been identified and explained in Table 2, the substantial equivalence comparison matrix.
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4100 E. Milham Avenue
Kalamazoo, MI 49001
t: 269 323 7700 f: 269 324 5412
www.stryker.com
Image /page/5/Picture/1 description: The image shows the Stryker Instruments logo. The word "stryker" is written vertically in a bold, sans-serif font. To the right of the word "stryker" is the word "Instruments" written vertically in a smaller, sans-serif font.
Table 2. Substantial equivalence comparison matrix
| Table 2. Substantial equivalence comparison matrix | |||
|---|---|---|---|
| Description | Stryker Bone and Vertebral Body Biopsy Kit(s) (Predicate) | Stryker® IVAS® 8 Gauge Bone Biopsy Kit (Subject) | Explanation of Differences |
| General Information | |||
| Classification | Class II | Class II | Identical |
| Regulation | 21 CFR 876.1075, Gastroenterology- | ||
| urology biopsy instrument | 21 CFR 876.1075, Gastroenterology- | ||
| urology biopsy instrument | Identical | ||
| Product code | KNW, Instrument, Biopsy | KNW, Instrument, Biopsy | Identical |
| Review panel | 78 Gastroenterology/Urology | 78 Gastroenterology/Urology | Identical |
| 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. | The Stryker iVAS Bone Biopsy Kit 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. | Identical |
| Use | Single-use | Single-use | Identical |
| Anatomical sites | Bone and vertebral body | Bone and vertebral body | Identical |
| Visualization technique | Fluoroscopy | Fluoroscopy | Identical |
| Method of placement | Percutaneous | Percutaneous | Identical |
| Mechanics of action | Manual | Manual | Identical |
| Mode of action | Suction | Suction | Identical |
| Shelf life | 2 years | 1 year | Similar – the intent is to extend the shelf life for the subject device upon successful completion of aging studies. |
| Description | Stryker Bone and Vertebral Body | ||
| Biopsy Kit(s) | |||
| (Predicate) | Stryker® IVAS® 8 Gauge Bone | ||
| Biopsy Kit | |||
| (Subject) | Difference | ||
| Size Information | |||
| Penetration | |||
| depth | 5 - 7.5-in. | 5 - 7.5-in. | Identical |
| Biopsy needle | |||
| and Obturator | Compatible with 10, 11 and 13-gauge | ||
| access cannulae/stylets | Compatible with 8-gauge access | ||
| cannula/stylet | The subject device biopsy needle | ||
| diameter increased to accommodate | |||
| user preference for an 8-gauge biopsy | |||
| system. Verification and validation | |||
| testing have been conducted to ensure | |||
| there are no new concerns of safety | |||
| and effectiveness. | |||
| Patient Contacting Material Information | |||
| Biopsy needle | Stainless steel | Stainless steel | Identical |
| Performance Information | |||
| Tensile force | |||
| (Pull test) | Withstand |