(20 days)
No
The summary describes a mechanical biopsy tool and does not mention any AI or ML components or functions.
No
The device is described as a "biopsy tool to remove sample tissue." This indicates it is used for diagnostic purposes, not for treating a disease or condition.
Yes
Explanation: The device is a biopsy tool used to remove sample tissue, which is then typically analyzed to diagnose medical conditions. This process falls under the definition of a diagnostic device.
No
The device description explicitly states it is a "Bone Biopsy Kit" and describes physical components like a needle and obturator, indicating it is a hardware device.
Based on the provided information, the Stryker iVAS® 13G Bone Biopsy Kit is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "remove sample tissue from bone or vertebral body using a coring, cutting or aspiration technique." This describes a procedure performed on the patient to obtain a sample, not a test performed on a sample outside the body to diagnose a condition.
- Device Description: The description reinforces its use as a "biopsy tool" for tissue removal.
- Lack of IVD Characteristics: There is no mention of analyzing the tissue sample, detecting specific substances, or providing diagnostic information based on the sample analysis. IVDs are designed to perform tests on biological samples (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
This device is a surgical tool used to obtain a sample, which may then be sent to a laboratory for in vitro diagnostic testing, but the device itself is not the diagnostic test.
N/A
Intended Use / Indications for Use
The Stryker iVAS® 13G 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 ®13G 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.
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
No clinical testing was deemed necessary for this 510(k).
Key Metrics
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 contains 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, which consists of the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
February 26, 2018
Stryker Corporation Ms. Kristi Ashton Staff Regulatory Affairs Specialist 4100 East Milham Avenue Kalamazoo, Michigan 49001
Re: K180327
Trade/Device Name: Stryker iVAS® 13G Bone Biopsy Kit Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: KNW Dated: February 5, 2018 Received: February 6, 2018
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 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 and Part 809); medical device reporting (reporting of
1
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.
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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) K180327
Device Name
Stryker iVAS ® 13G Bone Biopsy Kit
Indications for Use (Describe)
The Stryker iVAS® 13G 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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K180327 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
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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
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d. Date Submitted: February 23, 2018
2. Subject Device Name
Trade Name: Stryker iVAS ®13G Bone Biopsy Kit Common Name: Instrument, Biopsy Product Codes: KNW Classification: Class II Regulation: 21CFR876.1075
3. Legally Marketed Predicate Device
| Table 7-1-Predicate Device | |||
|---|---|---|---|
| -- | ---------------------------- | -- | -- |
| Predicate Device | 510(k) | Product Code | Manufacturer |
|---|---|---|---|
| Stryker iVAS® Bone Biopsy Kit (11G) | K172558 | KNW | Stryker Instruments |
K172558 represents the most recent clearance for the predicate device.
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| Reference Device | 510(k) | Product Code | Manufacturer |
|---|---|---|---|
| Coaxial Bone and Vertebral Body Biopsy | |||
| Needle (K070091) | K070091 | KNW | Stryker Instruments |
K070091 represents the most recent clearance for the reference device.
4. Device Description
The Stryker iVAS ®13G 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.
5. Principles of Operation/Mechanism of Action
The mechanism of action for obtaining a biopsy is manual and the principle of operation is through suction.
6. Intended Use/Indications for use
Stryker iVAS ®13G 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.
7. Comparison of Technological Characteristics with the Predicate Device
The subject and predicate devices are identical in the following ways:
- FDA product codes and ● regulation
- Intended use ●
- Indications for use
- Single-use, multiple samples per patient
- Placed percutaneously under ● fluoroscopy
- Manual suction ●
- Shelf life ●
- Material (needle & obturator)-● (patient contacting)
- . Material (sheath)-(non-patient contacting)
- Needle tip design ●
-
of teeth ●
- Penetration depth ●
- Needle/obturator length
- Sterilization method ●
- SAL
- Minimum sterilization dose ●
- Packaging configuration .
The subject and predicate devices differ in the following ways:
- Gauge size- The subject device is a 13G biopsy kit and the predicate device is an 11G biopsy kit. The 13G needle size is smaller than the 11G but this difference will not affect the performance of the subject device as demonstrated through testing. The
5
previously cleared Stryker 13G Coaxial Bone and Vertebral Body Biopsy Needle (K070091) is being used in this submission as a reference device due to its identical gauge size.
- Needle dimension- The subject device's needle dimensions are nominally smaller than . the predicate device. The change in the outer dimension does not change the performance of the device and does not raise new types of safety and effectiveness questions.
- Diameter (obturator)-The subject obturator is nominally smaller than the predicate . device. With the modification for a smaller size, the function and performance of the obturator remains the same. The obturator does not contact the patient. The smaller size does not raise new types of safety and effectiveness questions.
- . Handle colorant (needle)-The subject needle handle utilizes the same handle material as the predicate device. The difference in the subject and predicate needle handles relates to the colorants used. The colorant in the subject handle is a dark grey and the colorant in the predicate device handle is green. The handle color of the subject needle enables the end user to distinguish between different gauge sizes. The handle does not touch the patient and does not raise new types of safety and effectiveness questions.
- Handle colorant (obturator)-The subject and predicate obturator handles have the same . handle material. The difference in the subject and predicate obturator handles relates to the colorants used. The subject obturator handle is a dark grey and the predicate obturator handle is green. The handle color of the subject obturator enables the end user to distinguish between different gauge sizes. The handle does not touch the patient and does not raise new types of safety and effectiveness questions.
8. Non-Clinical
Biocompatibility:
A biocompatibility evaluation was completed on the Stryker iVAS Access Cannula, which has identical materials of construction and manufacturing process as the subject device. All testing completed met the requirements of the respective test methods as per the recommendations of ISO 10993-1 and FDA Guidance (Use of International Standard ISO-10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" June 2016) as appropriate for limited exposure (≤24 hours) externally communicating, tissue/bone/dentin devices.
Bench:
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 accordance with EN ISO 14971:2012 in an effort to mitigate risk where possible.
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All testing pertaining to the subject device modifications met their respective acceptance criteria as specified per the individual test report. Per the risk management assessment, the subject device does not introduce any new types of safety and effectiveness questions.
The following bench testing was conducted on the subject Stryker iVAS® Bone Biopsy Kit.
| Modification | Test Performed | Acceptance Criteria | Result |
|---|---|---|---|
| Material Information | |||
| Biopsy Handle | |||
| Colorant changed | |||
| from green to dark | |||
| grey | The biopsy needle handle does not touch the patient and is | ||
| thereby out of scope of ISO 10993. | N/A | ||
| Obturator Handle | |||
| Colorant changed | |||
| from green to dark | |||
| grey | The obturator does not touch the patient and is thereby out | ||
| of scope of ISO 10993. | N/A | ||
| Size Information | |||
| Modification | Test Performed | Acceptance Criteria | |
| Decreased biopsy | |||
| needle outer diameter | |||
| and inner diameter | |||
| (jaw size) to | |||
| accommodate user | |||
| preference for a 13G | |||
| Bone Biopsy Kit | Axial Torque | ||
| on the needle | Axial torque testing was completed to test how the | ||
| subject device withstands twisting. All samples surpassed | |||
| all acceptance criteria. | |||
| Non-axial | |||
| Torque on the | |||
| needle | Non-axial torque testing was completed to test how the | ||
| subject device withstands bending. All samples surpassed | |||
| all acceptance criteria. | |||
| Impact and | |||
| Compressive | |||
| Force on the | |||
| needle | Impact and compressive force was completed to simulate | ||
| impact and compression of the subject device while it is | |||
| being advanced into bone. All samples surpassed all | |||
| acceptance criteria. | |||
| Tensile Force | |||
| on needle | Tensile force testing was completed to verify the force | ||
| required to pull the needle off of the handle is higher than | |||
| the force needed to remove the device from bone. All | |||
| samples surpassed all acceptance criteria. | |||
| Decreased obturator | |||
| diameter to | |||
| accommodate user | |||
| preference for a 13G | |||
| Bone Biopsy Kit | Compressive | ||
| Force on the | |||
| obturator | Compressive force was completed to simulate | ||
| compression of the subject device when removing the | |||
| sample from the needle. All samples surpassed all | |||
| acceptance criteria. |
Table 7-2 Design Controls
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The device modification, assessed by the risk management file and validated with testing deemed necessary, does not introduce any new concerns regarding the safety and effectiveness of the subject device.
9. Clinical Testing
No clinical testing was deemed necessary for this 510(k).
10. Substantial Equivalence Conclusion
The Stryker iVAS ® Bone Biopsy Kit and the predicate device have the same intended use, fundamental scientific technology, principle of operation, and mode of action.
Although there are slight differences in the technological characteristics of the subject and predicate devices, these differences were found to be insignificant overall. In accordance with the Risk Management File (RMF), verification and validation testing demonstrates that the subject device has the same performance characteristics as the predicate device.
The modifications to the subject Stryker iVAS® Biopsy Kit do not raise new types of safety and effectiveness questions. Therefore it is proposed that the subject Stryker iVAS® Biopsy Kit is substantially equivalent to the predicate device, the Stryker iVAS® Bone Biopsy Kit (11G-K172558).