IVAS 8 GAUGE BONE BIOPSY KIT

K141673 · Stryker Corporation · KNW · Sep 4, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K141673
• Device Name: IVAS 8 GAUGE BONE BIOPSY KIT
• Applicant: Stryker Corporation
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Sep 4, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended 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.

Device Story

Disposable, single-use, sterile bone biopsy kit; includes coaxial biopsy needle, obturator, and syringe. Used with separately sold access cannula and stylet. Operates manually via percutaneous placement under fluoroscopic guidance. Biopsy needle removes bone tissue samples from vertebral bodies using coring, cutting, or aspiration techniques. Designed for use by clinicians in a clinical setting. Provides tissue samples for diagnostic evaluation; assists in clinical decision-making regarding vertebral pathology. Benefits patient by enabling minimally invasive tissue acquisition for diagnosis.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Stainless steel biopsy needle; manual operation; percutaneous access; fluoroscopic visualization. Sterilized via Gamma irradiation (VDmax25, 25 kGy, SAL 10^-6) per ISO 11137-1/2. 8-gauge diameter; non-swaged distal tip. Single-use, disposable. No software or electronic components.

Indications for Use

Indicated for patients requiring bone tissue biopsy from a vertebral body for diagnostic purposes.

Regulatory Classification

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.

Predicate Devices

• Stryker Bone and Vertebral Body Biopsy Kit (K032943)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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)

### 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)

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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<br>4100 E. Milham Avenue<br>Kalamazoo, Michigan 49001<br>USA<br>Ph: [phone]<br>Fax: [phone] |
|-----|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| b. | FDA Establishment<br>Registration Number: | 1811755 |
| c. | Contact Person: | Brittney M. Larsen<br>Ph: [phone]<br>Fax: [phone]<br>[e-mail] |
| 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<br>Name: | Gastroenterology-urology biopsy instrument<br>(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<br>Body Biopsy Kit | Stryker<br>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-<br>urology biopsy instrument | 21 CFR 876.1075, Gastroenterology-<br>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<br>Biopsy Kit(s)<br>(Predicate) | Stryker® IVAS® 8 Gauge Bone<br>Biopsy Kit<br>(Subject) | Difference |
| Size Information | | | |
| Penetration<br>depth | 5 - 7.5-in. | 5 - 7.5-in. | Identical |
| Biopsy needle<br>and Obturator | Compatible with 10, 11 and 13-gauge<br>access cannulae/stylets | Compatible with 8-gauge access<br>cannula/stylet | The subject device biopsy needle<br>diameter increased to accommodate<br>user preference for an 8-gauge biopsy<br>system. Verification and validation<br>testing have been conducted to ensure<br>there are no new concerns of safety<br>and effectiveness. |
| Patient Contacting Material Information | | | |
| Biopsy needle | Stainless steel | Stainless steel | Identical |
| Performance Information | | | |
| Tensile force<br>(Pull test) | Withstand < 15-lbs. of force | Withstand < 15-lbs. of force | Identical |
| Biopsy needle<br>tip | Swaged | Not swaged | Subject biopsy needle does not exhibit<br>a swaged, tapered, distal tip in order to<br>increase sample size. Verification and<br>validation testing have been conducted<br>to ensure there are no new concerns of<br>safety and effectiveness. |
| Sterilization Information | | | |
| Sterilization<br>method | Gamma irradiation, VDmax25 | Gamma irradiation, VDmax25 | Identical |
| Sterilization<br>assurance level<br>(SAL) | 10-6 | 10-6 | Identical |
| Minimum<br>sterilization<br>dose | 25-kilograys (kGy) | 25-kilograys (kGy) | Identical |

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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

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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:<br>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

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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).