(181 days)
Not Found
No
The device description and other sections do not mention any AI or ML components or functionalities. The device is a simple mechanical needle.
No
Explanation: The device is used for aspirating bone marrow, which is a diagnostic or collection procedure, not a therapeutic treatment.
No
The device is used to aspirate bone marrow, which is a procedure to collect tissue or fluid. It does not analyze the collected sample or diagnose a condition.
No
The device description clearly describes a physical needle made of stainless steel and plastic, which is a hardware component, not software.
Based on the provided information, the Ranfac Bone Marrow Aspiration Needle is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood or tissue, to detect diseases, conditions, or infections. They are used to examine specimens outside of the body.
- Device function: The Ranfac Bone Marrow Aspiration Needle is a tool used to collect a sample (bone marrow) from the body. It is a surgical or procedural device, not a diagnostic test performed on the collected sample.
The device's purpose is to obtain the sample, not to analyze it or provide diagnostic information itself. The diagnostic testing would be performed on the bone marrow sample after it has been collected using this needle.
N/A
Intended Use / Indications for Use
The Ranfac Bone Marrow Aspiration Needle is intended for use in aspirating bone marrow.
Product codes (comma separated list FDA assigned to the subject device)
KNW
Device Description
The Ranfac Bone Marrow Aspiration Needle is a single-use aspiration needle comprised of a stainless steel cannula with a molded plastic handle, and a stainless steel stylet with a molded plastic handle which mates with the cannula handle when the stylet is inserted through the cannula. While holding the mated handles, the user rotates the needle using a clockwise-counter clockwise motion while applying pressure on the bone. The needle bores into the marrow cavity. Once there the stylet is removed and aspiration is accomplished by attaching a luer syringe (not included) to the needle and applying negative pressure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone marrow
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
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.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
Image /page/0/Picture/0 description: The image shows a logo with the text "Ranfac" on the top right. The logo is divided into two parts. The top part is a horizontal line above the text, and the bottom part is a semi-circle. The left half of the semi-circle is filled with a dark color, while the right half is white.
Precision instruments for specialized applications
SECTION 5
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.
K131157
510(k) Summary
OCT 2 2 2013
Owner's Name and Address:
Ranfac Corporation 30 Doherty Avenue Avon, MA 02322-0635 FDA Registration Number 1211566
Official Contact Person:
Christopher P. Whelan Senior Vice President - Quality Telephone: 508-588-4400 extension: 106 Facsimile: 508-584-8588 e-mail: cwhelan@rantac.com
Ranfac Bone Marrow Aspiration Needle
Date Summary Prepared:
Device Trade Name:
Common Name:
October 21, 2013
Aspiration Needle, BMA Needle
Classification Name: Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: Class II . Product Code: KNW
RANFAC CORP. | PO BOX 635 | 30 DOHERTY AVE | AVON, MA 02322 | USA Phone: 508-588-4400 | 800-272-6322 | Fax: 508-584-8588 | Email info@ranfac.com www.ranfac.com
Since, 1888!
1
Image /page/1/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 with the left quarter filled in black. The logo appears to be for a company or organization named Ranfac.
Precision instruments for specialized applications
510(k) Summary
Predicate Device:
| 510(k) Number | Predicate Description | Manufactured By |
|---|---|---|
| K050795 | Imbibe Bone Marrow Aspiration Needle | Orthovita, Inc. |
| K100665 | MarrowMax Bone Marrow Aspiration Needle Kit | NeedleTech |
| K051506 | Sterylab Best Bone Harvesting System | Sterylab |
| Device Description: | The Ranfac Bone Marrow Aspiration Needle is a single-use
aspiration needle comprised of a stainless steel cannula
with a molded plastic handle, and a stainless steel stylet
with a molded plastic handle which mates with the cannula
handle when the stylet is inserted through the cannula.
While holding the mated handles, the user rotates the
needle using a clockwise-counter clockwise motion while
applying pressure on the bone. The needle bores into the
marrow cavity. Once there the stylet is removed and
aspiration is accomplished by attaching a luer syringe
(not included) to the needle and applying negative pressure. |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | The Ranfac Bone Marrow Aspiration Needle is intended
for use in aspirating bone marrow. |
| Technological Characteristics: | The Ranfac Bone Marrow Aspiration Needle is similar
in materials and design to the predicate device. Both
devices are comprised of stainless steel tubing for the
cannula and stainless steel wire for the stylet. Both devices
have plastic molded handles for the cannula and stylet that
mate with each other to prevent separation. Both devices
have side holes or no side holes to maximize aspiration and
both have luer lock connections enabling the use of
standard syringes. |
RANFAC CORP. | PO BOX 635 | 30 DOHERTY AVE | AVON, MA 02322 | USA Phone: 508-588-4400 | 800-272-6322 | Fax: 508-584-8588 | Email info@ranfac.com
Sincel 1888
2
Image /page/2/Picture/0 description: The image shows a logo with the text "Ranfac" on the top right. The logo is divided into two parts. The left part is a black semi-circle, and the right part is a white semi-circle. The logo is enclosed in a rectangular border.
Precision instruments for specialized applications
510(k) Summary
Non-clinical Data: Standards
''
The Stainless Steel, which is the only patient contacting material, and contacts the patient in a limited use 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.
The following standards apply to the sterilization of the finished device.
ISO 11135-1, Sterilization of health care products -Ethylene Oxide - Partl: 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 14-335.
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
RANFAC CORP. | PO BOX 635 | 30 DOHERTY AVE | AVON. MA 02322 | USA Phone: 508-588-4400 | 800-272-6322 | Fax: 508-584-8588 | Email info@ranfac.com www.ranfac.com
since | xxx
3
Image /page/3/Picture/0 description: The image shows a logo with the text "Ranfac" on the right side. On the left side of the text is a semi-circular shape that is half black and half white. Above the text and the semi-circle is a horizontal line.
Page 4 of 4
Precision instruments for specialized applications
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
Clinical Data:
Conclusion:
Not applicable
Based on the similarities in materials, design, principles of function, biocompatibility and sterilization between the Ranfac Bone Marrow Aspiration Needle, subject of this premarket notification and the predicate device, the Ranfac Bone Marrow Aspiration Needle has been shown to be substantially equivalent to the predicate device under the Federal Food, Drug and Cosmetic Act.
RANFAC CORP. | PO BOX 635 | 30 DOHERTY AVE | AVON. MA 02322 | USA Phone: 508-588-4400 | 800-272-6322 | Fax: 508-584-8588 | Email info@ranfac.com
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized symbol that resembles a bird or a person with outstretched arms, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002
October 22, 2013
Ranfac Corporation Mr. Christopher P. Whelan Senior Vice President - Quality 30 Doherty Avenue, P.O. Box 635 Avon, Massachusetts 02322
Re: K131157
Trade/Device Name: Ranfac Bone Marrow Aspiration Needle Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology-urology biopsy instrument Regulatory Class: Class II Product Code: KNW Dated: August 23, 2013 Received: August 29, 2013
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
5
Page 2 - Mr. Christopher P. Whelan
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
,: ·
ﺘ .
SECTION 4
Indications for Use
510(k) Number (if known): K131157
Device Name: Ranfac Bone Marrow Aspiration Needle
Indications for Use: The Ranfac Bone Marrow Aspiration Needle is intended for use in aspirating bone marrow.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Long H. Chen - A | for MXM | Page 1 of 2 |
|---|---|---|
| Digitally signed by Long H. Chen - A |
DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, cn=Long H. Chen - A, 0.9.2342.19200300.100.1.1=1300359056
Date: 2013.10.22 06:51:26 -04'00' | | |
| (Division Sign-off) | | |
| Division of Surgical Devices | | |
| 510(k) Number: K131157 | | |