(73 days)
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.
The Stryker® Inflatable Vertebral Augmentation System (iVAS®) 8 Gauge Bone Biopsy Kit may 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 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).
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Non-Clinical Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Impact testing | Biopsy needle to withstand impact loads of at least 25 cycles at 2-in-lb. | Not explicitly stated, but implied to have met criteria. The document states, "Stryker has determined that the device modification to the predicate device(s) raises no new questions of safety or effectiveness." |
| Tensile force testing | Biopsy needle and obturator to withstand a force measuring less than 15-lbs. | Not explicitly stated, but implied to have met criteria. |
| Non-axial torque testing | Biopsy needle handle to withstand a force measuring less than 25-in-lb. | Not explicitly stated, but implied to have met criteria. |
| Axial torque testing | Biopsy needle handle to withstand a force measuring less than 3.25-in-lb. | Not explicitly stated, but implied to have met criteria. |
| Functional testing | Non-swaged biopsy needle must retain an equivalent or greater average subjective size measurement than the swaged biopsy needle. | Not explicitly stated, but implied to have met criteria. The document states, "Verification and validation testing have been conducted to ensure there are no new concerns of safety and effectiveness." |
| 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 | Not explicitly stated, but implied to have met criteria. |
Important Note: The document consistently states that testing was performed to mitigate risk and ensure no new safety or effectiveness concerns, indicating that all acceptance criteria were met, even if the specific numerical results are not listed.
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide specific sample sizes for each non-clinical test. It generally refers to "verification and validation testing" without detailing the number of units tested for each criterion.
- Test Set Sample Size: Not specified.
- Data Provenance: The testing was non-clinical (laboratory/bench testing) performed by Stryker Instruments. The country of origin for the data is implicitly the USA (Kalamazoo, Michigan), where Stryker Instruments is located. The tests were prospective as they were performed to evaluate the modified device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Given that this is a 510(k) submission for a physical medical device (bone biopsy kit) and involves non-clinical bench testing, the concept of "experts establishing ground truth for a test set" in the context of image analysis or diagnostic performance is not directly applicable.
The "ground truth" for the non-clinical tests is established by the engineering specifications and regulatory standards (e.g., ISO 14971, ISO 11137-1/2) that define the performance metrics and their acceptance limits. The experts involved would be the design engineers, quality assurance personnel, and regulatory affairs specialists within Stryker who designed the tests, conducted them, and interpreted the results against these established standards. Their qualifications would be in engineering, materials science, and medical device regulations. The document does not specify the exact number of such individuals involved.
4. Adjudication Method for the Test Set
Again, for non-clinical bench testing of a physical device, an "adjudication method" as typically understood in studies involving human interpretation (e.g., 2+1 consensus) is not directly relevant.
The "adjudication" in this context would involve:
- Verification and validation testing protocols: These define how each test is to be performed and how results are to be interpreted.
- Quality control procedures: Internal company procedures ensure that testing is conducted correctly and documented accurately.
- Review and approval processes: Engineering and quality management teams would review the test results against the acceptance criteria. Any discrepancies or failures would lead to further investigation or device redesign.
The document states that a "Risk Management File (RMF), in compliance with EN ISO 14971:2012" was completed, indicating a structured process for risk assessment and verification activities.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical testing was deemed necessary for this 510(k)." Therefore, there is no information on how much human readers improve with AI vs. without AI assistance, as AI is not part of this device or its evaluation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This device is a physical bone biopsy kit, not an algorithm or AI-powered system.
7. The Type of Ground Truth Used
For the non-clinical tests, the "ground truth" is based on:
- Engineering specifications: Design requirements for physical strength, torque resistance, impact resistance, and functional performance (e.g., sample size retention).
- Regulatory standards: Compliance with international standards for sterilization (ISO 11137-1 and ISO 11137-2 for VDmax25, SAL 10-6) and risk management (EN ISO 14971:2012).
- Predicate device characteristics: The modified device's performance is compared to the established performance and safety profile of the predicate device (Stryker Bone and Vertebral Body Biopsy Kit K032943) to ensure substantial equivalence.
8. The Sample Size for the Training Set
This is not applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no training set for this physical device.
{0}------------------------------------------------
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
{2}------------------------------------------------
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
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 Instruments4100 E. Milham AvenueKalamazoo, Michigan 49001USAPh: +1-269-323-7700Fax: +1-269-324-5412 |
|---|---|---|
| b. | FDA EstablishmentRegistration Number: | 1811755 |
| c. | Contact Person: | Brittney M. LarsenPh: +1-269-389-5293Fax: +1-269-389-5412Brittney.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. | ClassificationName: | 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 VertebralBody Biopsy Kit | StrykerInstruments |
{4}------------------------------------------------
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.
{5}------------------------------------------------
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 BodyBiopsy Kit(s)(Predicate) | Stryker® IVAS® 8 Gauge BoneBiopsy Kit(Subject) | Difference |
| Size Information | |||
| Penetrationdepth | 5 - 7.5-in. | 5 - 7.5-in. | Identical |
| Biopsy needleand Obturator | Compatible with 10, 11 and 13-gaugeaccess cannulae/stylets | Compatible with 8-gauge accesscannula/stylet | The subject device biopsy needlediameter increased to accommodateuser preference for an 8-gauge biopsysystem. Verification and validationtesting have been conducted to ensurethere are no new concerns of safetyand effectiveness. |
| Patient Contacting Material Information | |||
| Biopsy needle | Stainless steel | Stainless steel | Identical |
| Performance Information | |||
| Tensile force(Pull test) | Withstand < 15-lbs. of force | Withstand < 15-lbs. of force | Identical |
| Biopsy needletip | Swaged | Not swaged | Subject biopsy needle does not exhibita swaged, tapered, distal tip in order toincrease sample size. Verification andvalidation testing have been conductedto ensure there are no new concerns ofsafety and effectiveness. |
| Sterilization Information | |||
| Sterilizationmethod | Gamma irradiation, VDmax25 | Gamma irradiation, VDmax25 | Identical |
| Sterilizationassurance level(SAL) | 10-6 | 10-6 | Identical |
| Minimumsterilizationdose | 25-kilograys (kGy) | 25-kilograys (kGy) | Identical |
{6}------------------------------------------------
4100 E. Milham Avenue
Kalamazoo, Ml 49001
t: 269 323 7700 f: 269 324 5412
www.stryker.com
Instrument
Table 2 continued. Substantial equivalence comparison matr
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the logo for Stryker Instruments. The word "Stryker" is in a 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
V. Non-clinical Testing
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. See Table 3, for a summary of the non-clinical testing and acceptance criteria used to evaluate the subject device modification. Stryker has determined that the device modification to the predicate device(s) raises no new questions of safety or effectiveness.
| Non-Clinical Testing | Acceptance Criteria |
|---|---|
| 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 |
Table 3. Non-clinical testing and acceptance criteria summary
VI. Clinical Testing
No clinical testing was deemed necessary for this 510(k).
VII. Conclusion / Substantial Equivalence (SE) Rationale
The Stryker® iVAS® 8 Gauge Bone Biopsy Kit is substantially equivalent in intended use, indications for use, technological characteristics, safety and effectiveness to the previously cleared Stryker Bone and Vertebral Body Biopsy
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the logo for Stryker Instruments. The word "stryker" is in bold, black letters, 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 font.
4100 E. Milham Avenue Kalamazoo, MI 49001 t: 269 323 7700 f: 269 324 5412 www.stryker.com
Conclusion/Substantial Equivalence (SE) Rationale continued.
Kit. The predicate device(s) have the same fundamental scientific technology, basic design, functional characteristics and applications. The device modification does not introduce any new concerns of safety or effectiveness. Therefore, the Stryker® iVAS® 8 Gauge Bone Biopsy Kit is substantially equivalent to the existing predicate device(s).
§ 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.