SWANNSHIDI BONE MARROW ASPIRATION NEEDLE

K121181 · Alliance Partners, LLC · KNW · Aug 22, 2012 · Gastroenterology, Urology

Device Facts

• Record ID: K121181
• Device Name: SWANNSHIDI BONE MARROW ASPIRATION NEEDLE
• Applicant: Alliance Partners, LLC
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Aug 22, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

The SwannShidi Bone Marrow Aspiration Needle is to be used for aspiration of bone marrow or autologous blood by use of a standard syringe.

Device Story

SwannShidi Bone Marrow Aspiration Needle; 15ga needle with angled tip stylet; includes depth gauge with graduated scale and locking mechanism; luer lock connection for standard syringe attachment. Single-use, sterile, disposable device. Used by clinicians for bone marrow or autologous blood aspiration. Device facilitates sample collection via manual aspiration; provides depth control for clinician. Benefits include standardized, controlled access for marrow/blood aspiration.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

15ga stainless steel needle; angled tip stylet; medical grade plastic components; luer lock connection; depth gauge with graduated scale/locking mechanism; ethylene oxide sterilization.

Indications for Use

Indicated for aspiration of bone marrow or autologous blood using a standard syringe.

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

• Busse Hospital Disposables I-Style Bone Marrow Aspiration Needle (K061570)
• H.S. Hospital Service S.p.A. BMN "I" Type Marrow Biopsy Needle (K020987)
• Ranfac Corporation Goldenberg SNARECOIL Needle (K031344)

Submission Summary (Full Text)

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# K121181

## 510(k) Summary

Summary of 510(k) Safety and Effectiveness

Submitted By:

Alliance Partners, LLC 121 Interpark Blvd, #601 San Antonio, TX 78216

Date:

August 13. 2012

Jennifer Palinchik Regulatory Consultant

[phone]

Contact Person:

Contact Telephone:

Device Trade Name: Device Classification Name: Device Classification: Reviewing Panel: Regulation Number: Product Code: Predicate Device:

SwannShidi Bone Marrow Aspiration Needle Gastroenterology-urology biopsy instrument Class II Gastroenterology/Urology 876.1075 KNW Busse Hospital Disposables I-Style Bone Marrow Aspiration Needle (K061570) H.S. Hospital Service S.p.A. BMN "I" Type Marrow Biopsy Needle (K020987) Ranfac Corporation Goldenberg SNARECOIL Needle (K031344)

### Device Description:

The SwannShidi Bone Marrow Aspiration Needle consists of a 15ga needle and an angled tip stylet of corresponding size. A depth gauge with graduated scale and additional locking mechanism allows for adjustment of the penetration section of the needle. A luer lock connection is provided to allow aspiration of bone marrow or autologous blood by use of a standard surgical syringe. The SwannShidi is a single use, disposable device that will be supplied sterile.

### Intended Use:

The SwannShidi Bone Marrow Aspiration Needle is to be used for aspiration of bone marrow or autologous blood by use of a standard syringe.

## Substantial Equivalence Information:

The design features, principles of operation, materials, indications for use, biocompatibility, and sterilization method of the SwannShidi are substantially equivalent to the predicate devices listed

AUG 2222012

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K121181 Page 2 of 2

above. The minor technological differences between the SwannShidi and its predicate devices raise no issues of safety and effectiveness.

Predicate Comparison Summary Table:

| Item | SwannShidi | Busse Hospital<br>Disposables I-<br>Style Bone<br>Marrow | H.S. Hospital<br>Service BMN<br>"I" Type<br>Marrow Biopsy | Ranfac<br>Goldenberg<br>SNARECOIL<br>Needle |
|------------------------------------|--------------------------------------------------------------------------------------------|----------------------------------------------------------|---------------------------------------------------------------------------------------|-------------------------------------------------------|
| | | Aspiration<br>Needle | Needle | |
| Product<br>Code | KNW | KNW | KNW | KNW, FCG |
| Regulation<br>Name | Gastroenterology-<br>urology biopsy<br>instrument | Gastroenterology-<br>urology biopsy<br>instrument | Gastroenterology-<br>urology biopsy<br>instrument | Gastroenterology-<br>urology biopsy<br>instrument |
| Intended Use | for aspiration of<br>bone marrow or<br>autologous blood<br>by use of a<br>standard syringe | for aspiration of<br>bone marrow | for drawing of<br>osteomedullary<br>substance or for<br>explanation of<br>bone marrow | for obtaining a<br>percutaneous soft<br>tissue biopsy |
| Needle Size | 15 gauge | Same | Same | 11-16 gauge |
| Stylet | Yes | Yes | Yes | Yes |
| Angled Tip | Yes | Yes | Yes | Yes |
| Male luer<br>connection | Yes | Yes | Yes | Yes |
| Material-<br>Needle/Stylet | Stainless Steel | Same | Same | Same |
| Material-<br>Plastic<br>Components | Medical Grade<br>Plastic | Same | Same | Same |
| Sterilization<br>Method | Ethylene Oxide | Same | Same | Same |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

#### Public Health Service

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

Alliance Partners, LLC % Ms. Jennifer Palinchik Regulatory Consultant 121 Interpark Boulevard, # 601 San Antonio, Texas 78216

AUG 2222012

## Re: K121181

Trade/Device Name: SwannShidi Bone Marrow Aspiration Needle Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: Class II Product Code: KNW Dated: August 13, 2012 Received: August 14, 2012

Dear Ms. Palinchik:

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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## Page 2 - Ms. Jennifer Palinchik

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson
Director
Division of Surgical, Orthopedic

Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K121181

Device Name: SwannShidi Bone Marrow Aspiration Needle

## Indications for Use:

The SwannShidi Bone Marrow Aspiration Needle is to be used for aspiration of bone marrow or autologous blood by use of a standard syringe.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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 (ODE)

Neil R. Doyle formxm

(Division Sign-Of Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K121181