I-STYLE BONE MARROW ASPIRATION NEEDLE

K061570 · Busse Hospital Disposables, Inc. · KNW · Jul 3, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K061570
• Device Name: I-STYLE BONE MARROW ASPIRATION NEEDLE
• Applicant: Busse Hospital Disposables, Inc.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Jul 3, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

The I-Style Bone Marrow Aspiration Needle is to be used for the aspiration of bone marrow.

Device Story

I-Style Bone Marrow Aspiration Needle is a sterile, single-use, disposable device used for bone marrow aspiration. It consists of an 8ga-15ga needle and a triple-sharpened atraumatic tip stylet. Features include an adjustable depth stopper and graduated scale for penetration control, and a luer lock connection on the molded handle for attachment to a standard surgical syringe. The device is used by clinicians in a clinical setting to extract bone marrow or blood samples. The needle is provided individually or as part of a Bone Marrow Biopsy Tray.

Clinical Evidence

Bench testing only. Biocompatibility testing performed including L929 Men Elution Test, Kligman Maximization Test, Intracutaneous Injection Test, Systemic Injection Test, and Salmonella Typhimurium and Escherichia Coli Reverse Mutation Assay.

Technological Characteristics

Needle sizes 8ga-15ga; triple-sharpened atraumatic tip stylet; adjustable depth stopper; graduated scale; luer lock connection; sterile, single-use, disposable. Materials evaluated via biocompatibility testing.

Indications for Use

Indicated for the aspiration of bone marrow. Patient population not specified.

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

• Manan Bone Marrow Aspiration Needle

Submission Summary (Full Text)

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K061570

## SUMMARY

and the country of the comments of

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS ASPIRATION NEEDLE

| Regulatory Affairs Contact: | Muhamad Ansari<br>Busse Hospital Disposables<br>PO Box: 11067<br>75 Arkay Dr.<br>Hauppauge NY 11788 |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone: | 631-435-4711 Ext: 254 |
| Fax: | 631-435-2849 |
| Date Summary prepared: | May 31, 2006 |
| Product Trade Name: | I-Style Bone Marrow Aspiration Needle |
| Common Name: | Bone Marrow Biopsy Aspiration Needle. |
| Classification: | Class II, 21 CFR 868.5150 |
| Product Code: | KNW |
| Predicate Device: | Manan Bone Marrow Aspiration Needle |
| Device Description: | The I-Style Bone Marrow Aspiration Needle<br>consists of an 8ga - 15ga needle and a triple<br>sharpened atraumatic tip stylet of corresponding<br>size. The needle is manufactured in lengths upto 2"<br>with an adjustable depth stopper and graduated<br>scale which allow for the adjustment of the<br>penetration length of the needle. A luer lock<br>connection is provided in the molded needle handle<br>to allow aspiration of bone marrow or blood by use<br>of a standard surgical syringe.<br>The needle will be provided as sterile, single use,<br>disposable device. They will be packaged<br>individually or included in Bone Marrow Biopsy<br>Tray. |

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The I-Style Bone Marrow Aspiration Needle is to be used for the aspiration of bone marrow.

## 510(k) SUMMARY OF SUBSTANTIAL EQUIVALENCE

Summary of Testing: All materials used in the fabrication of the specialty needles were evaluated through biological qualification safety tests. The biocompatibility tests performed were L929 Men Elution Test, Kligman Maximization Test, Intracutaneous Injection Test, Systemic Injection Test, Salmonella Typhimurium and Escherichia Coli Reverse Mutation Assay These materials have met the testing requirements and were found to be acceptable for the intended use. Summary of tests performed to prove the substantial

equivalence of the Aspiration Needles with the predicate device:

- 1. Same intended use
- 2. Same flow rate
- 3. Same bonding strength

Technological Characteristics: [21 CFR 807.92(a)(6)]

The subject device has the same Technological Characteristics as a legally marketed predicate device.

Conclusion: [21 CFR 807.92(b)(3)]

The above statements are accurate representations of the device Busse intents to market. All data and information submitted in this premarket notification is truthful and accurate and no material fact has been omitted.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 3 2006

Busse Hospital Disposables % Mr. Muhamad Ansari Director. Regulatory Affairs P.O. Box 11067 Hauppauge, New York 11788-0920

Re: K061570

Trade/Device Name: I-Style Bone Marrow Aspiration Needle Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: KNW Dated: May 31, 2006 Received: June 6. 2006

Dear Mr. Ansari:

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 docs 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 -- Mr. Muhamad Ansari

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/cdrl/industry/support/index.html.

Sincerely yours,

Helen Levenson
Mark N. Molkerson

r Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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FDA 510(k) Premarket Notification

## INDICATIONS FOR USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: 1-Style Bone Marrow Aspiration Needle.

Indication for Use: The I-Style Bone Marrow Aspiration Needle is intended for Aspiration of Bone Marrow.

Prescription Use_ × (Per 21 CFR 801Subpart D) AND/OR

Over-The-Counter Use_ (Per 21 CFR 801Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hulbert Lemon

Division of General, Restorative. and Neurological Devices

**510(k) Number** K061570