IMBIBE BONE MARROW ASPIRATION NEEDLE

K050795 · Orthovita, Inc. · KNW · Jun 3, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K050795
• Device Name: IMBIBE BONE MARROW ASPIRATION NEEDLE
• Applicant: Orthovita, Inc.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Jun 3, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

The Imbibe Bone Marrow Aspiration 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.

Device Story

Imbibe Bone Marrow Aspiration Needle; manual surgical instrument for bone marrow or autologous blood aspiration. Components: 8ga or 11ga needle; trocar tip stylet; bullet tip stylet; molded handle with female luer connection. Operation: needle inserted into bone; aspiration performed via standard surgical syringe; bullet tip stylet used for repositioning; surgical hammer used for placement if required. 8ga version includes distal fenestrated holes to increase aspiration area. Used by clinicians in surgical settings. Output: aspirated bone marrow or blood for clinical use with bone graft or void fillers.

Clinical Evidence

Bench testing only. Mechanical and performance testing verified device met all specifications and performed equivalently to predicate devices.

Technological Characteristics

Manual aspiration needle; 8ga or 11ga diameter; 10cm or 15cm lengths; female luer connection; trocar and bullet tip stylets; optional distal fenestrations. Non-powered, mechanical device.

Indications for Use

Indicated for aspiration of bone marrow or autologous blood via syringe for clinical use, including potential combination with bone graft or bone void filler.

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

• Bone Marrow Harvest Needle (K940025)
• Bone Biopsy Needle (K001132)
• Aspirex - Bone Marrow Aspiration Kit (K041991)

Submission Summary (Full Text)

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[K050795]

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## 510(k) SUMMARY

### IMBIBE Bone Marrow Aspiration Needle

Orthovita, Inc. 45 Great Valley Parkway Malvern, PA 19355

Phone: [phone] (610)-640-2603 Facsimile:

| Contact Person: | David McIlhenny |
|-----------------|--------------------------------|
| | Sr. Vice President, Operations |

March 10, 2005 Date Prepared:

## Name of Device

Imbibe™ Bone Marrow Aspiration Needle

# Common or Usual Name

Aspiration Needle, BMA Needle

## Classification Name

Needle, Aspiration and Injection, Disposable (Product Code GAA)

## Predicate Devices

| 510(K) Number | Predicate Description | Manufactured By |
|---------------|--------------------------------------|-----------------------|
| K940025 | Bone Marrow Harvest Needle | Manan Medical |
| K001132 | Bone Biopsy Needle | Promex |
| K041991 | Aspirex - Bone Marrow Aspiration Kit | Isotis Orthobiologics |

## Intended Use / Indications for Use

The Imbibe Bone Marrow Aspiration 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.

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## Technological Characteristics

The Imbibe Bone Marrow Aspiration Needle consists of an 8ga or 11ga needle, trocar tip stylet of corresponding size, and bullet tip stylet of corresponding size. The needle will be manufactured in two lengths measuring 10cm or 15cm from tip to molded handle. A female luer is provided on the molded needle handle to allow aspiration of bone marrow or blood by use of a standard surgical syringe. One version of the 8ga needle provides fenestrated holes on the distal end of the needle. The fenestrated holes in the distal end of the needle are designed to provide more area for bone marrow or blood to enter the needle during aspiration. The bullet tip stylet must be inserted into the needle, after initial needle placement, if repositioning of the needle is required. If required, the needle can be lightly tapped with a surgical hammer for placement.

### Performance Data

Performance testing provided in the submission indicates that the Imbibe Bone Marrow Aspiration Needle met all of the established specifications. Mechanical and performance testing verified that the Imbibe Bone Marrow Aspiration Needle is substantially equivalent to the predicate devices for bone marrow aspiration and does not raise any new issues of safety and effectiveness.

### Summary Basis for the Finding of Substantial Equivalence

The Imbibe Bone Marrow Aspiration Needle is substantially equivalent to the predicate devices. The Imbibe Bone Marrow Aspiration Needle has the same intended uses and similar indications, technological characteristics and principles of operation. The minor technological differences between the Imbibe Bone Marrow Aspiration Needle and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrates the Imbibe Bone Marrow Aspiration Needle is as safe and effective as the predicate devices. Thus, the Imbibe Bone Marrow Aspiration Needle is substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 3 - 2005

Orthovita Incorporated C/o Ms. Janice M. Hogan Regulatory Counsel Hogan & Hartson, L.L.P 1835 Market Street, 2811 Floor Philadelphia, Pennsylvania 19103

Re: K050795

Trade/Device Name: Imbibe Bone Marrow Aspiration Needle Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: KNW Dated: March 24, 2005 Received: March 29, 2005

Dear Ms. Hogan:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Ms. Janice M. Hogan

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone] . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Rulida

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological 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):_

Device Name: Imbibe Bone Marrow Aspiration Needle

Indications for Use:

The Imbibe Bone Marrow Aspiration 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.

Prescription Use X (Per 21 C.F.R. 801.109) OR

Over-The-Counter Use_

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Concurrence of CDRH, Office of Device Evaluation (ODE)

K050795