(42 days)
No
The device description and performance studies focus on the mechanical aspects of a manual biopsy tool and do not mention any AI/ML components or capabilities.
No
The device is described as a "biopsy tool to remove sample tissue." Biopsy tools are diagnostic devices, not therapeutic devices.
Yes
The device is a biopsy tool used to remove sample tissue from bone or vertebral body for diagnostic purposes, as indicated by "Used in patients in need of a bone or vertebral body tissue diagnostics" and the description of the device's function to obtain samples for pathological analysis.
No
The device description clearly outlines physical components (needles, obturator, syringe) and manual mechanisms of action, indicating it is a hardware-based medical device.
Based on the provided information, the Stryker iVAS® Bone Biopsy Kit is not an IVD (In Vitro Diagnostic).
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, prevention, or treatment of a disease or condition. This examination is performed outside of the body (in vitro).
- Device Function: The Stryker iVAS® Bone Biopsy Kit is a tool used to collect a tissue sample from bone or the vertebral body. It is a surgical instrument used within the body (in vivo) to obtain the specimen.
- Intended Use: The intended use is to "remove sample tissue from bone or vertebral body using a coring, cutting or aspiration technique." This describes the process of obtaining the sample, not the analysis of the sample itself.
- Device Description: The description focuses on the mechanical aspects of the device (manual mechanism, suction principle, components like needle, obturator, syringe). It does not mention any components or functions related to analyzing the collected tissue.
- Performance Studies: The performance studies described are related to the mechanical integrity and functionality of the biopsy kit (torque, force, impact). They do not involve any analysis of biological samples or diagnostic performance metrics.
The collected tissue sample will likely be used for in vitro diagnostic testing (e.g., pathology, histology), but the biopsy kit itself is the tool for obtaining the sample, not the diagnostic device that performs the analysis.
N/A
Intended Use / Indications for Use
The Stryker iVAS® Bone Biopsy Kit can be used as a biopsy tool to remove sample tissue from bone or vertebral body using a coring, cutting or aspiration technique.
Product codes
KNW
Device Description
The Stryker iVAS® Bone Biopsy Kit can be used as a biopsy tool to remove sample tissue from bone or vertebral body using a coring, cutting or aspiration technique. The subject device is disposable, intended for single use, and is provided sterile to the end user. The mechanism of action for obtaining a biopsy is manual and the principle of operation is through suction. The biopsy device will be sold in a kit configuration consisting of a coaxial biopsy needle, obturator and syringe. The subject biopsy kit is used with an access cannula and stylet of compatible size. The access cannula and stylet are sold separately and are Class I exempt per 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
Not Found
Anatomical Site
bone or 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)
Bench testing was conducted on the subject Stryker iVAS® Bone Biopsy Kit.
Axial Torque and Non-axial Torque (11G) was performed to verify torsional performance of the subject device. All samples surpassed all acceptance criteria.
Compressive force testing was completed on the obturator (10G) to simulate compression during clinical use. All samples surpassed all acceptance criteria.
Axial Tensile Force (10G) was performed to verify the functional performance of the subject device at T=0. All samples surpassed all acceptance criteria.
Compressive Force and Axial Tensile Force was performed on the obturator (11G) to verify functional and compressive performance. All samples surpassed all acceptance criteria.
Impact and Axial Compressive testing was to verify the impact and compressive performance of the subject device. All samples surpassed all acceptance criteria.
Impact testing was performed on the subject device to confirm functional specifications. All samples surpassed all acceptance criteria.
The acceptance criteria for the predicate devices is similar to the acceptance criteria for the subject bone biopsy kit, demonstrating equivalence of the subject device to the predicate biopsy devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
October 5, 2017 Stryker Corporation Ms. Kristi Ashton Staff Regulatory Affairs Specialist 4100 E. Milham Avenue Kalamazoo, Michigan 49001
Re: K172558
Trade/Device Name: Stryker iVAS Bone Biopsy Kit . Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: KNW Dated: August 23, 2017 Received: August 24, 2017
Dear Ms. Ashton:
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 pror 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, 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 of medical device-related adverse events) (21 CFR 803); 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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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 (DICE) 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (DICE) 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.
Sincerely,
Jennifer R. Stevenson -S3
For 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)
Device Name Stryker iVAS® Bone Biopsy Kit
Indications for Use (Desarbe) The Stryker iVAS® Bone Biopsy Kit can be used as a biopsy tool to remove sample tissue from bone or vertebral body using a coring, cutting or aspiration technique.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | ☑ |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
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K172558 510(k) Summary
1. Submitter
| 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: | Kristi Ashton, BSN, RN
Staff Regulatory Affairs Specialist
Regulatory Affairs
Instruments Division
Stryker Corporation
Ph: +1-269-389-5929
Fax: +1-269-389-5412
Kristi.Ashton@Stryker.com |
| d. Date Submitted: | October 2, 2017 |
2. Subject Device Name
Trade Name: Stryker iVAS® Bone Biopsy Kit Common Name: Instrument, Biopsy Product Codes: KNW
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K172558 Stryker iVAS® Bone Biopsy Kit
Regulation: 21CFR876.1075 3. Legally Marketed Predicate Device
Predicate Device: Coaxial Bone and Vertebral Body Biopsy Needle (K070091) Reference Device: Stryker iVAS® 8G Bone Biopsy Kit (K141673) 4. Device Description
The Stryker iVAS® Bone Biopsy Kit can be used as a biopsy tool to remove sample tissue from bone or vertebral body using a coring, cutting or aspiration technique. The subject device is disposable, intended for single use, and is provided sterile to the end user. The mechanism of action for obtaining a biopsy is manual and the principle of operation is through suction. The biopsy device will be sold in a kit configuration consisting of a coaxial biopsy needle, obturator and syringe. The subject biopsy kit is used with an access cannula and stylet of compatible size. The access cannula and stylet are sold separately and are Class I exempt per 21 CFR 888.4200, product code OAR (injector, vertebroplasty (does not contain cement).
5. Intended Use/Indications for use
The Stryker iVAS® Bone Biopsy Kit can be used as a biopsy tool to remove sample tissue from bone or vertebral body using a coring, cutting or aspiration technique.
6. Comparison of Technological Characteristics with the Predicate Device
Table 5-1 Comparison of Technological Characteristics
| Description | Stryker iVAS® Biopsy Kit
(Subject) | Coaxial Bone and Vertebral Body
Biopsy Needle
(K070091)
(Predicate) |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | Class II | Class II |
| Product code | KNW, Instrument, Biopsy | KNW, Instrument, Biopsy |
| Description | Stryker iVAS® Biopsy Kit
(Subject) | Coaxial Bone and Vertebral Body
Biopsy Needle
(K070091)
(Predicate) |
| Indications for use | The Stryker iVAS® Bone Biopsy
Kit can be used as a biopsy tool to
remove sample tissue from bone
or vertebral body using a coring,
cutting or aspiration technique. | This device is intended for use by
a physician performing a bone or
vertebral body biopsy using a
coring, cutting, or aspiration
technique. |
| Intended use/target
population | Used in patients in need of a bone
or vertebral body tissue
diagnostics | Used in patients in need of a bone
or vertebral body tissue
diagnostics |
| Gauge
Configurations | 8G,10G,11G | 10G, 11G, 13G |
| Biopsy needle
Dimensions | The differences in the dimensions
are nominal across the gauge
sizes. | The differences in the dimensions
are nominal across the gauge sizes. |
| Biopsy Needle-
Material | Stainless steel | Stainless steel |
| Biopsy Needle
Handle Material | Plastic | Plastic |
| Biopsy needle
sheath (safety
feature) | Plastic | Plastic |
| Penetration depth | There are nominal differences in
the penetration depth of the
subject and predicate devices. | There are nominal differences in
the penetration depth of the subject
and predicate devices. |
| Jaw size | There are nominal differences in
the jaw size of the subject and
predicate devices. | There are nominal differences in
the jaw size of the subject and
predicate devices. |
| Brush Size (diameter
and depth) | N/A | N/A |
| Obturator Material | Stainless steel | Stainless steel |
| Description | Stryker iVAS® Biopsy Kit
(Subject) | Coaxial Bone and Vertebral Body
Biopsy Needle
(K070091)
(Predicate) |
| Obturator Handle
Material | Plastic | Stainless Steel |
| Sterilization method | Gamma Irradiation, VDmax25 | Ethylene Oxide (Eo) |
| Sterilization
assurance level | 10-6 | 10-6 |
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8. Non-Clinical
Biocompatibility:
The materials of construction for the Stryker iVAS ® Bone Biopsy Kit have not changed since the device was originally cleared via K032943 (10G, 11G) and K141673 (8G). Therefore, biocompatibility testing is not required.
Bench:
The following bench testing was conducted on the subject Stryker iVAS® Bone Biopsy Kit. The testing was conducted in a manner as similar as possible to how the biopsy device will be used by the healthcare professional.
Axial Torque and Non-axial Torque (11G) was performed to verify torsional performance of the subject device. All samples surpassed all acceptance criteria.
Compressive force testing was completed on the obturator (10G) to simulate compression during clinical use. All samples surpassed all acceptance criteria.
Axial Tensile Force (10G) was performed to verify the functional performance of the subject device at T=0. All samples surpassed all acceptance criteria.
Compressive Force and Axial Tensile Force was performed on the obturator (11G) to verify functional and compressive performance. All samples surpassed all acceptance criteria.
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Impact and Axial Compressive testing was to verify the impact and compressive performance of the subject device. All samples surpassed all acceptance criteria.
Impact testing was performed on the subject device to confirm functional specifications. All samples surpassed all acceptance criteria.
The acceptance criteria for the predicate devices is similar to the acceptance criteria for the subject bone biopsy kit, demonstrating equivalence of the subject device to the predicate biopsy devices.
9. Clinical Testing
No clinical testing was deemed necessary for this 510(k).
10. Substantial Equivalence Conclusion
The Stryker iVAS ® Bone Biopsy Kit and predicate devices have the same fundamental scientific technology, principal of operation and mode of action.
The addition of bone to the intended use for the subject device does not raise new questions of safety and effectiveness. A review of recalls, Maude data, clinical literature, and a risk review was completed. There are no new or previously unidentified complications or additional harms associated with the use of biopsy needles when the indication is expanded to include bone.
Although there are a few differences in the technological characteristics of the subject and predicate devices, they are insignificant overall. The technological differences between the subject and predicate devices do not raise new types of safety and effectiveness questions. The performance testing completed proves that the subject device has the same performance characteristics as the predicate device.
Therefore it is proposed that the subject Stryker iVAS® Biopsy Kit is substantially equivalent to the predicate device (Coaxial Bone and Vertebral Body Biopsy Needle (K070091).