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.

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.

AI/ML Overview

The provided document is a 510(k) summary for the Stryker iVAS® 13G Bone Biopsy Kit. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific performance acceptance criteria in the context of an AI/human-in-the-loop diagnostic device.

Therefore, many of the requested elements for an AI medical device study (such as MRMC studies, expert consensus for ground truth, sample sizes for training sets, etc.) are not applicable to this specific document as it pertains to a mechanical biopsy device.

However, I can extract the information related to the acceptance criteria and the "study" (bench testing) that proves the device meets those criteria, as detailed in the "Non-Clinical" section.

Here's the breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Test Performed)	Description of Acceptance Criteria	Reported Device Performance (Result)
Biocompatibility Evaluation	Meet requirements 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) for limited exposure (≤24 hours) externally communicating, tissue/bone/dentin devices.	All testing completed met the requirements of the respective test methods.
Bench Testing - Material Information (Handles) Biopsy Handle Colorant Changed Obturator Handle Colorant Changed	Biopsy needle handle does not touch the patient and is out of scope of ISO 10993. Obturator does not touch the patient and is out of scope of ISO 10993.	N/A (Explanation provided that these components are not patient-contacting and therefore out of scope for biocompatibility testing).
Bench Testing - Size Information (Needle) Axial Torque on the needle	Device withstands twisting (specific quantitative criteria are not detailed but implied by "surpassed all acceptance criteria"). Each test would have a defined torque value it needed to withstand.	All samples surpassed all acceptance criteria.
Bench Testing - Size Information (Needle) Non-axial Torque on the needle	Device withstands bending (specific quantitative criteria are not detailed but implied by "surpassed all acceptance criteria").	All samples surpassed all acceptance criteria.
Bench Testing - Size Information (Needle) Impact and Compressive Force on the needle	Simulate impact and compression during advancement into bone. Each test would have a defined force value it needed to withstand.	All samples surpassed all acceptance criteria.
Bench Testing - Size Information (Needle) Tensile Force on needle	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.
Bench Testing - Size Information (Obturator) Compressive Force on the obturator	Simulate compression of the device when removing the sample from the needle.	All samples surpassed all acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

The document states "All samples surpassed all acceptance criteria" for various bench tests, but does not specify the exact sample sizes (N). It implies that multiple units were tested for each criterion.
Data Provenance: The testing was "non-clinical" (bench testing) performed by Stryker Instruments. The country of origin for the data is implicitly the USA, where Stryker is headquartered and testing would likely take place. The testing is prospective in the sense that it was conducted specifically to address the risks and demonstrate equivalence for this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not Applicable. For a mechanical device, "ground truth" as it applies to diagnostic accuracy (e.g., expert consensus on medical images) is not relevant. The "truth" for these tests is based on engineering specifications and physical measurements (e.g., how much force something can withstand).

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations of data for diagnostic purposes. For mechanical bench testing, results are typically objective measurements against engineering specifications, not subject to subjective interpretation requiring adjudication.

5. 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 is a mechanical biopsy device, not an AI-powered diagnostic tool. No MRMC study was performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a mechanical biopsy device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical bench testing was based on engineering specifications and pre-defined acceptance criteria derived from risk assessment (EN ISO 14971:2012). This includes quantitative measurements of physical properties (e.g., force, torque limits). For biocompatibility, the ground truth was compliance with ISO 10993-1 and FDA guidance.

8. The Sample Size for the Training Set

Not Applicable. This is a mechanical device, not an AI model, so there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not Applicable. As there is no training set, this question is not relevant.

Summary of Relevant Information:

The study proving the device meets acceptance criteria was non-clinical bench testing and biocompatibility evaluation, as detailed in section 8 of the 510(k) summary. These tests were conducted according to established engineering and material standards to ensure the device's mechanical integrity and biological safety after design modifications (specifically, changes in gauge size and handle colorants). The acceptance criteria were based on the device's ability to withstand various physical stresses and to be biocompatible, and all tested samples reportedly met these criteria. The details regarding specific quantitative thresholds for "acceptance criteria" are not provided in this 510(k) summary, but it states "All samples surpassed all acceptance criteria", implying successful performance against pre-defined internal specifications.

Summary

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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

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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

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: 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 BiopsyNeedle (K070091)	K070091	KNW	Stryker Instruments

K070091 represents the most recent clearance for the reference device.

4. Device Description

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

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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 HandleColorant changedfrom green to darkgrey		The biopsy needle handle does not touch the patient and isthereby out of scope of ISO 10993.	N/A
Obturator HandleColorant changedfrom green to darkgrey		The obturator does not touch the patient and is thereby outof scope of ISO 10993.	N/A
Size Information
Modification	Test Performed	Acceptance Criteria
Decreased biopsyneedle outer diameterand inner diameter(jaw size) toaccommodate userpreference for a 13GBone Biopsy Kit	Axial Torqueon the needle	Axial torque testing was completed to test how thesubject device withstands twisting. All samples surpassedall acceptance criteria.
	Non-axialTorque on theneedle	Non-axial torque testing was completed to test how thesubject device withstands bending. All samples surpassedall acceptance criteria.
	Impact andCompressiveForce on theneedle	Impact and compressive force was completed to simulateimpact and compression of the subject device while it isbeing advanced into bone. All samples surpassed allacceptance criteria.
	Tensile Forceon needle	Tensile force testing was completed to verify the forcerequired to pull the needle off of the handle is higher thanthe force needed to remove the device from bone. Allsamples surpassed all acceptance criteria.
Decreased obturatordiameter toaccommodate userpreference for a 13GBone Biopsy Kit	CompressiveForce on theobturator	Compressive force was completed to simulatecompression of the subject device when removing thesample from the needle. All samples surpassed allacceptance 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).

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.