Imbibe Needle

K153306 · Orthovita, Inc. · KNW · Dec 18, 2015 · Gastroenterology, Urology

Device Facts

• Record ID: K153306
• Device Name: Imbibe Needle
• Applicant: Orthovita, Inc.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Dec 18, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

The Imbibe Needle is for use in aspirating bone marrow or autologous blood by use of a syringe. The bone marrow or autologous blood may be combined with bone graft or bone void filler. The Imbibe Needle is also for use in the placement of guidewires (e.g. k-wires) during orthopedic surgery.

Device Story

Manually operated surgical instrument; used for aspirating bone marrow or autologous blood via syringe; facilitates placement of guidewires (e.g., k-wires) during orthopedic surgery; guidewires assist in hardware placement (e.g., pedicle screws); used in clinical/surgical settings by orthopedic surgeons; device is identical to predicate (K140414) except for packaging design; benefits include safe, efficient access for aspiration and guidewire delivery.

Clinical Evidence

No clinical data. Substantial equivalence is supported by previous mechanical, cadaveric, and biocompatibility testing of the predicate device, supplemented by design verification and validation of the new packaging.

Technological Characteristics

Manually operated surgical instrument; identical to predicate device; materials, design, and principles of operation are unchanged.

Indications for Use

Indicated for patients undergoing orthopedic surgery requiring bone marrow or autologous blood aspiration, or placement of guidewires (e.g., k-wires) for hardware implantation.

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 Imbibe Needle (K140414)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure, with three faces in profile, suggesting care and support.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Orthovita Incorporated Ms. Lynn Lundy, MBA, RAC Senior Regulatory Affairs Specialist 77 Great Valley Parkway Malvern, Pennsylvania 19355

December 18, 2015

Re: K153306

Trade/Device Name: Imbibe Needle Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: KNW, LXH Dated: November 13, 2015 Received: November 16, 2015

Dear Ms. Lundy:

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 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.

{1}------------------------------------------------

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), 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/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 at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Joshua C. Nipper -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. For 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) K153306

Device Name Imbibe Needle

Indications for Use (Describe)

The Imbibe Needle is for use in aspirating bone marrow or autologous blood by use of a syringe. The bone marrow or autologous blood may be combined with bone graft or bone void filler.

The Imbibe Needle is also for use in the placement of guidewires (e.g. k-wires) during orthopedic surgery.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| <div> <span> </span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div> <span> </span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

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 [e-mail]

"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}------------------------------------------------

## 8. 510(k) Summary

| 510(k) Summary: Imbibe Needle | |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Stryker Orthobiologics<br>77 Great Valley Parkway<br>Malvern, PA 19355 |
| Contact Person | Lynn Lundy, MBA, RAC<br>Senior Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared | November 13, 2015 |
| Trade Name | Imbibe Needle |
| Common Name | Gastroenterology-urology biopsy instrument |
| Proposed Class | Class II |
| Classification Names and Numbers | Instrument, Biopsy 21 CFR §876.1075<br>Orthopedic Manual Surgical Instrument 21 CFR §888.4540 |
| Product Code | KNW LXH |
| Predicate Devices | Stryker Imbibe Needle (K140414) |
| Device Description | The Imbibe Needle is a manually operated surgical instrument to assist with the aspiration of autologous blood or bone marrow and/or placing guidewires (e.g. k-wires) for orthopedic surgery. These guidewires may be used to place other hardware utilized in orthopedic procedures including pedicle screws. |
| Intended Use | The Imbibe Needle is for use in aspirating bone marrow or autologous blood by use of a syringe. The bone marrow or autologous blood may be combined with bone graft or bone void filler.<br>The Imbibe Needle is also for use in the placement of guidewires (e.g. k-wires) during orthopedic surgery. |
| Summary of the Technological Characteristics | As established in this submission, the Imbibe Needle was shown to be substantially equivalent and has equivalent technological characteristics to its predicate device through comparison in areas including intended use, material composition, principles of operation and design. |
| Summary of the Performance Data | The new Imbibe Needle, subject of this Special 510(k), is the same device as the predicate. Previous testing of the predicate device (i.e. mechanical, cadaveric testing and biocompatibility) has demonstrated that Imbibe Needle is safe and effective for its intended use. |
| Conclusion | The proposed Imbibe Needle has identical indications, technological |
| | <b>510(k) Summary: Imbibe Needle</b><br>characteristics, and principles of operation as its predicate. The only<br>difference between the new and the predicate device is the design of the<br>package. A risk analysis was performed to demonstrate the Imbibe Nee |

{4}------------------------------------------------

mbibe Needle package. TTSK andrysis was performed to demonstrate the mione Noodle
with new packaging is substantially equivalent to the predicate device. The design verifications and validations performed as a result of the risk analysis and presented herein demonstrate the proposed device does not raise new questions of safety or effectiveness. Thus, the predicate device (K140414) and proposed device are considered substantially equivalent.