RANFAC ASPIRATION NEEDLE WITH ADJUSTABLE GUIDE

K140991 · Ranfac, Corp. · KNW · Sep 11, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K140991
• Device Name: RANFAC ASPIRATION NEEDLE WITH ADJUSTABLE GUIDE
• Applicant: Ranfac, Corp.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Sep 11, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

The Ranfac Aspiration Needle with Adjustable Guide is intended for use for aspiration of bone marrow or autologous blood using a standard piston syringe.

Device Story

Device is a manual aspiration needle used for bone marrow or autologous blood collection. Consists of stainless steel cannula and two stainless steel stylets with ABS plastic handles. User inserts needle into bone marrow cavity by applying pressure and twisting handles; stylet is removed and replaced with a blunt stylet; needle is advanced to depth set by adjustable guide. Aspiration performed by attaching standard piston syringe to Luer fitting and applying negative pressure. Used in clinical settings by healthcare professionals. Benefits include controlled depth aspiration and ability to sample multiple areas via partial withdrawal.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, material compliance with ISO standards, and design similarity to predicate devices.

Technological Characteristics

Stainless steel cannula and stylets (ISO 9626); ABS plastic handles; adjustable depth guide; Luer lock connections (ISO 594/1, ISO 594-2). Sterilization via Ethylene Oxide (ISO 11135-1, ISO 10993-7). Manual operation; no energy source or software.

Indications for Use

Indicated for aspiration of bone marrow or autologous blood in patients requiring such procedures.

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

• Ranfac Bone Marrow Aspiration Needle (K131157)
• SwannShidi Bone Marrow Aspiration Needle (K121181)

Submission Summary (Full Text)

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

September 11, 2014

Ranfac Corporation Mr. Christopher P. Whelan Senior Vice President 30 Doherty Avenue Avon, Massachusetts 02322

Re: K140991

Trade/Device Name: Ranfac Aspirating Needle with Adjustable Guide Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology-biopsy instrument Regulatory Class: Class II Product Code: KNW Dated: September 2, 2014 Received: September 3, 2014

Dear Mr. Whelan:

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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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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 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,

# David Krause -S

Radiological Health

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

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known) K140991

Device Name

Ranfac Aspirating Needle with Adjustable Guide.

Indications for Use (Describe)

The Ranfac Aspiration Needle with Adjustable Guide is intended for use for aspiration of bone marrow or autologous blood using a standard piston syringe.

Type of Use (Select one or both, as applicable)

ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY CONTR

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/3/Picture/0 description: The image shows a logo for a company called Ranfac. The logo is split into two halves, with the left half being black and the right half being white. The word "Ranfac" is written in black letters above the logo. The logo is a semi-circle shape.

# SECTION 5

# K140991 510(k) Summary

The contents of this 510(k) summary on the following pages have been provided in conformance with 21 CFR § 807.92 Content and format of a 510(k) summary.

# 510(k) Summary

Owner's Name and Address:

Official Contact Person:

Date Summary Prepared:

Device Trade Name:

Common Name:

Classification Name:

Ranfac Corp. 30 Doherty Avenue Avon, MA 02322-0635 FDA Registration Number 1211566

Christopher P. Whelan Senior Vice President Telephone: [phone] extension: 106 Facsimile: 508-584-8588 e-mail: [e-mail]

April 15, 2014

Ranfac Aspiration Needle with Adjustable Guide

Needle, Aspiration and Injection, Disposable

Gastroenterology-urology biopsy instrument (KNW) Subpart B Diagnostic Devices 21 CFR § 876.1075, Gastroenterology-urology biopsy instrument, Class II

# 510(k) Summary

RANFAC CORP. | PO BOX 635 | 30 DOHERTY AVE | AVON, MA 02322 | USA 800-272-6322 | Fax: [phone] Phone: [phone] -Email [e-mail]

www.ranfac.com

sincc 1888

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Image /page/4/Picture/0 description: The image shows a logo with the text "Ranfac" on the top right. There is a horizontal line above the text. Below the text is a semi-circle that is split in half, with the left half being black and the right half being white.

# 510(k) Summary

#### Predicate Device:

| 510(k)<br>Number | Predicate Description | Manufactured By |
|------------------|------------------------------------------|------------------------|
| K131157 | Ranfac Bone Marrow Aspiration Needle | Ranfac Corp. |
| K121181 | SwannShidi Bone Marrow Aspiration Needle | Alliance Partners, LLC |

#### Background

The Ranfac Aspiration Needle with Adjustable Guide is a variation of the Ranfac Bone Marrow Aspiration Needle (K131157). The Ranfac Aspiration Needle with Adjustable Guide is intended for use for aspiration of bone marrow or autologous blood using a standard piston syringe. The Ranfac Aspiration Needle with Adjustable Guide works in a similar manner to the Ranfac Bone Marrow Aspiration Needle in that it enters the bone by the user applying pressure to the needle/stylet while twisting the handles. Once the needle enters the marrow cavity, the Stylet is removed and a Blunt Stylet is inserted and the needle is advanced to the desired location as set by the Adjustable Guide. Aspiration is performed by attaching a syringe to the Luer fitting of the needle and applying negative pressure. The needle can be partially withdrawn to continue to aspirate from different areas prior to complete withdrawal.

#### Device Description:

The Ranfac Aspiration Needle with Adjustable Guide consists of a stainless steel cannula, and two stainless steel stylets. All of the aforementioned have handles molded of ABS plastic. The cannula has an Adjustable Guide, also molded of ABS plastic that can be used as a depth guide.

RANFAC CORP. | PO BOX 635 | 30 DOHERTY AVE | AVON, MA 02322 | USA Fax: [phone] || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || Phone: [phone] Email [e-mail]

www.ranfac.com

sincc 1888

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Image /page/5/Picture/0 description: The image shows a logo with the text "Ranfac" at the top. Below the text is a semi-circular shape that is divided vertically into two halves. The left half of the semi-circle is filled with a solid black color, while the right half is white with a black outline.

# 510(k) Summary

The Ranfac Aspiration Needle with Adjustable Guide is intended for use for aspiration of bone marrow or autologous blood using a standard piston syringe.

The Ranfac Aspiration Needle with Adjustable Guide is similar in materials and design to the predicate devices. All devices are comprised of stainless steel cannula and stylets with mating plastic handles. All devices have luer fittings enabling the use of standard piston syringes.

The Stainless Steel Cannula and Stylets, contact the patient in a limited use, and is in conformance with ISO 9626 First edition 1991-09-01, Amendment 1 2001-06-01 Stainless steel needle tubing for the manufacture of medical devices. FDA Standards Recognition Number 6-163.

The luer lock connection that is molded as part of the plastic handle is in conformance with ISO 594/1 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements. FDA Standards Recognition Number 6-11.

The luer lock connection that is molded as part of the plastic handle is in conformance with ISO 594-2 Second edition 1998-09-01, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings. FDA Standards Recognition Number 6-129.

RANFAC CORP. | PO BOX 635 | 30 DOHERTY AVE | AVON, MA 02322 | USA Phone: [phone] | 800-272-6322 | Fax: [phone] Email [e-mail]

www.ranfac.com

Intended Use:

## Technological Characteristics:

### Non-clinical Data: Standards

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Image /page/6/Picture/0 description: The image shows a logo for a company called Ranfac. The logo is a semi-circular shape that is divided into two halves. The left half is filled with black, and the right half is white. The word "Ranfac" is written in a sans-serif font above the semi-circle.

The following standards apply to the sterilization of the finished device.

ISO 11135-1, Sterilization of health care products -Ethylene Oxide - Part1: Requirements for development, validation and routine control of a sterilization process for medical devices. FDA Recognition Number 14-331.

ISO 10993-7, Biological evaluation of medical devices -Part 7: Ethylene oxide sterilization residuals. FDA Recognition Number 14-278.

AAMI/ANSI/ISO 14161:2009, Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results. FDA Recognition Number 14-285

ISO 11607-1:2006, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems. FDA Recognition Number 14-355

#### Not applicable

Clinical Data:

Conclusion:

Based on the similarities in materials, design, principles of function, biocompatibility and sterilization between the Ranfac Aspiration Needle with Adjustable Guide, subject of this premarket notification and the predicate devices, the Ranfac Aspiration Needle with Adjustable Guide has been shown to be substantially equivalent to the predicate devices under the Federal Food, Drug and Cosmetic Act.

RANFAC CORP. | PO BOX 635 | 30 DOHERTY AVE | AVON, MA 02322 | USA Phone: [phone] | 800-272-6322 | Fax: [phone] | Email [e-mail]

www.ranfac.com

since 1888