IMBIBE NEEDLE

K140414 · Orthovita, Inc. · LXH · Apr 1, 2014 · Orthopedic

Device Facts

• Record ID: K140414
• Device Name: IMBIBE NEEDLE
• Applicant: Orthovita, Inc.
• Product Code: LXH · Orthopedic
• Decision Date: Apr 1, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.4540
• Device Class: Class 1

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; consists of handle, cannula, and removable stylet. Used for aspiration of autologous blood or bone marrow via syringe; also facilitates placement of orthopedic guidewires (e.g., k-wires). Operates by manual insertion; trocar or beveled stylet tip options available. Used in clinical/surgical settings by healthcare professionals. Provides access for fluid collection or hardware placement; assists in orthopedic procedures involving bone graft or void filler. Benefits include simplified aspiration and precise guidewire positioning.

Clinical Evidence

Bench testing only; mechanical and cadaveric testing performed to validate performance for aspiration and guidewire placement.

Technological Characteristics

Manual surgical instrument; handle with cannula and removable stylet. Materials: Externally communicating device with tissue/blood contact (<24 hours). Features: Trocar or beveled stylet tip, fenestrated option, male luer connection. Sterilization: Gamma irradiation (10^-6 SAL).

Indications for Use

Indicated for patients requiring bone marrow or autologous blood aspiration, or placement of guidewires (e.g., k-wires) during orthopedic surgical procedures.

Regulatory Classification

Identification

An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.

Predicate Devices

• Imbibe Needle (K050795)

Submission Summary (Full Text)

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## APR 0 1 2014

#### 510(k) SUMMARY Stryker Imbibe Needle

## February 18th, 2014

#### K140414 510(k) Number (if known):

#### 1. Contact Person

John Urtz Senior Regulatory Affairs Specialist (e-mail) [e-mail]

Orthovita, Inc. 77 Great Valley Parkway Malvern, PA 19355 (t) 610-407-7450 - (f) 484-323-8803

#### 2. Device Name and Classification

Product Name: Classification Name:

Common or Usual Name: Regulation Number:

Reviewing Panel:

Device Class: Product Code: Imbibe Needle Instrument, Biopsy Orthopedic Manual Surgical Instrument Gastroenterology-urology biopsy instrument 876.1075 888.4540 Gastroenterology/Urology Surgical, Orthopedic, and Restorative Devices Class II KNW LXH

#### 3. Predicate Device(s)

Orthovita Inc.'s Imbibe Needle (K050795)

#### 4. 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. kwires) for orthopedic surgery. These guidewires may be used to place other hardware utilized in orthopedic procedures including pedicle screws.

#### 5. Indications for 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.

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### 6. Performance Data

ﺎﻧﻴﺔ ﺍﻟﺘﻲ

Preclinical bench data supplied including mechanical and cadaveric testing demonstrates that the Imbibe Needle is substantially equivalent to the predicate device and any differences do not raise new questions of safety and effectiveness. Further, this testing supports the Imbibe Needle's ability to assist in the placement of guidewires.

## 7. Substantial Equivalence

| | Imbibe Needle<br>Predicate Device<br>K050795 | Imbibe Needle<br>New Device<br>TBD |
|------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| INDICATIONS FOR<br>USE | The Imbibe Needle is for use in<br>aspirating Bone Marrow or<br>autologous blood by use of a<br>syringe. The bone marrow or<br>autologous blood may be combined<br>with bone graft or bone void filler. | The Imbibe Needle is for use in<br>aspirating bone marrow or autologous<br>blood by use of a syringe. The bone<br>marrow or autologous blood may be<br>combined with bone graft or bone void<br>filler.<br>The Imbibe Needle is also for use in<br>the placement of guidewires (e.g. k-<br>wires) during orthopedic surgery. |
| PRODUCT CODE | KNW | KNW, LXH |
| PRODUCT DESIGN | Handle with cannula, removable | Handle with cannula, removable stylet |
| STYLET TIP DESIGN | Trocar | Trocar, Beveled |
| FENESTRATED<br>OFFERING | Y es | Yes |
| MALE LUER<br>CONNECTION FOR<br>SYRINGE<br>ATTACHMENT | Yes | Yes |
| STERILIZATION AND<br>SAL | Gamma irradiation, 10-6 | Gamma irradiation, 10-6 |
| BIOCOMPATIBILITY | Externally communicating device<br>with tissue/blood/dentin contact for<br>a duration of less than 24 hours | Externally communicating device with<br>tissue/blood/dentin contact for a<br>duration of less than 24 hours |

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features the department's name encircling a symbol. The symbol is a stylized representation of an eagle or bird-like figure, with three curved lines forming the body and wings.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

April 1, 2014

Orthovita Incorporated Mr. John Urtz Senior Regulatory Affairs Specialist 77 Great Valley Parkway Malvern, Pennsylvania 19355

Re: K140414

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: February 18, 2014 Received: February 18, 2014

Dear Mr. Urtz:

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 cither 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 r that FDA has made a determination that your device complies with other requirements of the Act that I Dr Hoo master and regulations administered by other Federal agencies. You must Or any I cachar statines and regiraments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical Cl N F art 6077, abouting (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. John Urtz

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Felipe Aquel

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use Statement

510(k) Number (if known):_K140414

Device Name: Imbibe Needle

Indications for 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.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR Over-The Counter Use x (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation

Felipe Aguel

Date: 2014.04.01 16:08:02 -04'00'