(37 days)
No
The device description and performance studies focus on mechanical aspects and structural integrity, with no mention of AI or ML.
No.
The device is intended for the aspiration of bone marrow or autologous blood, which are diagnostic or collection procedures, not therapeutic treatments.
No
Explanation: The device is intended for the aspiration of bone marrow or autologous blood, which are procedures for collection of samples, not for diagnosis. The device description and intended use focus on the physical aspects of collecting the sample, not on analyzing it to determine a medical condition.
No
The device description clearly details physical components like needles, cannulas, and a stylet, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the aspiration of bone marrow or autologous blood. This is a procedure to collect a sample from the body.
- Device Description: The device is a needle designed for physically accessing and withdrawing a sample from the bone marrow.
- Lack of Diagnostic Function: The description focuses on the mechanics of sample collection. There is no mention of the device being used to analyze the collected sample or provide any diagnostic information about the patient's condition. IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening.
This device is a tool for sample collection, which is a step that might precede an in vitro diagnostic test, but the device itself does not perform the diagnostic test.
N/A
Intended Use / Indications for Use
The Ranfac FLEX Bone Marrow Aspiration (BMA) Needle is intended for aspiration of bone marrow or autologous blood using a standard piston syringe.
Product codes (comma separated list FDA assigned to the subject device)
KNW
Device Description
The Ranfac FLEX BMA Needle subject of this premarket notification is a manual, sterile disposable needle intended for the purpose of aspirating bone marrow or autologous blood. The device consists of an Access Needle for bone marrow penetration and an Aspirator Cannula through which the aspirate is obtained. The Access Needle is provided with an integral threaded Adjustable Guide which acts as a depth stop for control of needle penetration depth and when turned counterclockwise allows for the Aspiration Cannula to be withdrawn backwards through the bone marrow needle tract in a controlled manner (as opposed to manually pulling back the needle or Aspiration Cannula). The distal tip of the Aspiration Cannula is closed and provided with side holes to allow the physician to aspirate from the sides of the needle (to minimize blood within the aspirate). The Aspiration Cannula has a flexed tip which will redirect if the tip encounters the wall of the marrow cavity. The Access Needle is 8 gauge with an effective length of 3 inches. An exchangeable Drillable Stylet is provided for use with the device which can mate to a standard surgical drill to aid bone penetration if needed.
The device is packaged with the following commercially available, 510k cleared accessory devices:
- . Standard 10mL luer lock hypodermic syringe (Becton Dickinson K980580, cleared June 25, 1998 or equivalent 510(k) cleared hypodermic syringe)
- . J-Type Bone Marrow Biopsy Needle (RJN Needle manufactured by Ranfac Corp. reference K190177, cleared June 12, 2019 – the RJN Needle assembly includes a needle with stylet, probe tip, probe cannula and trap cannula).
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)
Structural integrity testing was conducted on the Ranfac FLEX BMA Needle demonstrating robustness and appropriateness of the design. All samples met or exceeded acceptance criteria. Strength specifications are similar to those of the predicate Ranfac Marrow Cellution Bone Marrow Aspiration Needle. Additionally, simulated use and cadaver testing was performed to validate that the design output of the Ranfac FLEX BMA Needle met design input requirements.
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.
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 the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
September 18, 2020
Ranfac Corporation Eric Kreuz Vice President of Quality Assurance/Regulatory Affairs 30 Doherty Street Avon, Massachusetts 02322
Re: K202287
Trade/Device Name: Ran-Flex-B 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 10, 2020 Received: August 12, 2020
Dear Eric Kreuz:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202287
Device Name
Ranfac FLEX Bone Marrow Aspiration (BMA) Needle (RAN-FLEX-B)
Indications for Use (Describe)
The Ranfac FLEX Bone Marrow Aspiration (BMA) Needle is intended for aspiration of bone marrow or autologous blood using a standard piston syringe.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Traditional 510(k) – Ranfac Flex Bone Marrow Aspiration Needle Ranfac Corp.
Image /page/3/Picture/2 description: The image shows the logo for Ranfac, with the text "Ranfac" in a teal color. The logo also includes a shield-like design with a gold color. The text "Page 1 of 7" is located at the top of the image.
510(k) Summary
Submission Type: Traditional 510(k)
Submitter Information:
Ranfac Corp. 30 Doherty Ave Avon, MA
Contact Person:
Eric Kreuz Director of Quality Assurance/Regulatory Affairs Ranfac Corp. 30 Doherty Ave. Avon, MA 02332 Telephone 508-588-4400 ext. 137 Fax: 508-584-8588 e-mail: ekreuz@ranfac.com
Date Prepared:
August 10, 2020
Subject Device Information:
| Proprietary Name: | Ranfac FLEX BMA Needle |
|---|---|
| Common Name: | Biopsy Needle |
| Classification Name: | Instrument, Biopsy |
| Regulation: | 21 CFR 876.1075 |
| Product Code: | KNW |
| Device Classification: | Class II |
| Classification Panel: | Gastroenterology/Urology |
Predicate Devices:
| Proprietary Name: | Ranfac Marrow Cellution Needle (K150563) |
|---|---|
| Common Name: | Biopsy Needle |
| Classification Name: | Instrument, Biopsy |
| Regulation: | 21 CFR 876.1075 |
| Product Code: | KNW |
| Device Classification: | Class II |
| Classification Panel: | Gastroenterology/Urology |
4
Image /page/4/Picture/2 description: The image shows the Ranfac logo with the text "Page 2 of 7" at the top. The logo features the word "Ranfac" in a teal, sans-serif font above a shield-like emblem. The shield is divided vertically, with the left half appearing to be a textured, light-gold color and the right half being white. A registered trademark symbol is visible at the bottom of the shield.
The Ranfac FLEX BMA Needle is considered substantially equivalent to the Ranfac Marrow Cellution Needle cleared under 510(k) Premarket Notification K150563 on May 22, 2015 (primary predicate). The selected primary predicate is appropriate based on similarity in intended use, principle of operation as well as materials and other technological characteristics between it and the Ranfac FLEX BMA Needle. Further, the same manufacturing and sterilization processes are used by Ranfac for the subject and predicate devices.
Where differences exist between the subject and predicate device, the following devices are used to bridge these differences and therefore serves as reference predicates.
| Reference Predicate Devices | ||||
|---|---|---|---|---|
| Device Trade Name: | Ranfac Bone | |||
| Marrow Biopsy | ||||
| Needle | MarrowMiner | OnControl Bone | ||
| Marrow Aspiration | ||||
| System | ||||
| Manufacturer: | Ranfac | StemCor Systems, | ||
| Inc. | VidaCare Corp. (now | |||
| Teleflex) | ||||
| 510(k) Number: | K190177 | K071732 | K072045 | |
| Device Common Name: | Biopsy Needle | Biopsy Instrument | Biopsy Needle | |
| Classification: | Biopsy Instrument | |||
| / Class II per | ||||
| §876.1075 / | ||||
| Procode | ||||
| KNW/FCG | Biopsy Instrument / | |||
| Class II per | ||||
| §878.4820 / | ||||
| Procode GDM/GAA | Biopsy Instrument / | |||
| Class II per | ||||
| §876.1075 / Procode | ||||
| KNW/FCG | ||||
| Classification Panel: | Gastroenterology | |||
| / Urology | General & Plastic | |||
| Surgery | Gastroenterology / | |||
| Urology | ||||
| Reason for Reference | ||||
| Predicate | To cover the | |||
| characteristic for | ||||
| an 8 gauge needle | To cover the flexible | |||
| shaft | To cover attribute for | |||
| an exchangeable drill | ||||
| insert |
Device Description:
The Ranfac FLEX BMA Needle subject of this premarket notification is a manual, sterile disposable needle intended for the purpose of aspirating bone marrow or autologous blood. The device consists of an Access Needle for bone marrow penetration and an Aspirator Cannula through which the aspirate is obtained. The Access Needle is provided with an integral threaded Adjustable Guide which acts as a depth stop for control of needle penetration depth and when turned counterclockwise allows for the Aspiration Cannula to be withdrawn backwards through the bone marrow needle tract in a controlled manner (as opposed to manually pulling back the needle or Aspiration
5
Image /page/5/Picture/2 description: The image shows the Ranfac logo with the text "Page 3 of 7" at the top. The logo is a shield divided vertically into two halves. The left half is a solid tan color, while the right half is white. The word "Ranfac" is written in a teal color above the shield. A registered trademark symbol is located at the bottom of the shield.
Cannula). The distal tip of the Aspiration Cannula is closed and provided with side holes to allow the physician to aspirate from the sides of the needle (to minimize blood within the aspirate). The Aspiration Cannula has a flexed tip which will redirect if the tip encounters the wall of the marrow cavity. The Access Needle is 8 gauge with an effective length of 3 inches. An exchangeable Drillable Stylet is provided for use with the device which can mate to a standard surgical drill to aid bone penetration if needed.
The device is packaged with the following commercially available, 510k cleared accessory devices:
- . Standard 10mL luer lock hypodermic syringe (Becton Dickinson K980580, cleared June 25, 1998 or equivalent 510(k) cleared hypodermic syringe)
- . J-Type Bone Marrow Biopsy Needle (RJN Needle manufactured by Ranfac Corp. reference K190177, cleared June 12, 2019 – the RJN Needle assembly includes a needle with stylet, probe tip, probe cannula and trap cannula).
Indications for Use:
The Ranfac FLEX Bone Marrow Aspiration Needle is intended for aspiration of bone marrow or autologous blood using a standard piston syringe.
Comparison of Technological Characteristics to the Predicate Device:
The Ranfac FLEX BMA Needle is substantially equivalent in intended use, principles of operation and fundamental technological characteristics to the legally marketed predicate Marrow Cellution device. The table below summarizes the similarities and differences in design, materials and dimensions between the subject and predicate device.
| | FLEX BMA Needle
(This Submission) | Marrow Cellution (K150563) |
|------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation
Number | 21 CFR §876.1075 | 21 CFR §876.1075 |
| Intended Use | For harvest of bone marrow
tissue | For harvest of bone marrow
tissue |
| Indication for Use | For use for aspiration of bone
marrow or autologous blood
using a standard piston
syringe. | For use for aspiration of bone
marrow or autologous blood
using a standard piston syringe. |
| Ranfac Marrow Cellution Needle | | |
| | FLEX BMA Needle
(This Submission) | Marrow Cellution (K150563) |
| Performance
Characteristics | Needle bores into bone to
access marrow cavity | Needle bores into bone to
access marrow cavity |
| Overall Product
Design | Single-use, sterile disposable
needle to acquire tissue
specimen. The device is
comprised of an outer cannula
with handle and an inner stylet
and Aspiration Cannula with
flexible stainless steel coil
tubing tip. Includes an integral
threaded Adjustable Guide
that when turned counter-
clockwise allows for the
aspiration cannula to be
withdrawn backwards through
the marrow (rather than
manually pulling back on the
aspiration cannula). Needle
has depth markings every
centimeter. | Single-use, sterile disposable
needle to acquire tissue
specimen. The device is
comprised of an outer cannula
with handle and an inner stylet
and an Aspiration Cannula with
rigid stainless steel tip. Includes
an integral threaded Adjustable
Guide that when turned
counter-clockwise allows for the
needle to be withdrawn
backwards through the marrow
(rather than manually pulling
back on the needle). Needle has
depth markings every
centimeter. |
| Mechanics of
Operation | Manual instrument | Manual instrument |
| Patient/Tissue
Contact
Materials | Stainless steel and plastic | Stainless steel and plastic |
| Access Needle
Gauge x Length | 8 gauge by 3 inch 304 stainless
steel needle with cm etched
depth markings and ABS T-
Handle | 11 Gauge by 4 or 6 inch 304
stainless steel needle with cm
etched depth markings and ABS
T-Handle |
| Needle Cutting
Tip Configuration | Stylet has beveled 3-sided
trocar tip and needle cannula
has 5-sided grind tip for
penetration | Stylet has beveled 3-sided trocar
tip and needle cannula has 5-
sided grind tip for penetration –
also provided with blunt tip
stylet |
| Table 5-1. Comparison of the Ranfac FLEX BMA Needle with the Predicate | | |
| Ranfac Marrow Cellution Needle | | |
| | | |
| | FLEX BMA Needle
(This Submission) | Marrow Cellution (K150563) |
| Aspiration
Cannula
Configuration | 11 gauge 316L stainless steel
hollow cannula with welded
flexible 316L stainless steel
distal end. The very distal end
of the cannula is closed with
side ports for aspiration.
Provided with ABS luer and
snap fit T-handle. Provided
with Stylet. | 14 gauge x 304 stainless steel
hollow cannula with one set of
side ports and ABS luer. |
| Aspiration
Cannula Working
Length | 9.8 inches nominal | 9.2 inches nominal |
| Handle
Configuration | T-Shaped Handle Configuration | T-Shaped Handle Configuration |
| Adjustable Depth
Guide | Yes | Yes |
| Drillable Stylet | Yes | No |
| Packaging | Components in PETG tray
placed in Tyvek/Mylar Pouch | Tyvek/Mylar Pouch |
| Sterilization | Supplied Sterile via Ethylene
Oxide validated to 10-6 Sterility
Assurance Level | Supplied Sterile via Ethylene
Oxide validated to 10-6 Sterility
Assurance Level |
| Shelf-Life | 6 months | 5 years |
Table 5-1. Comparison of the Ranfac FLEX BMA Needle with the Predicate Ranfac Marrow Cellution Needle
6
Image /page/6/Picture/2 description: The image shows the Ranfac logo, which is a shield shape with a gold left half and a white right half. The word "Ranfac" is written in teal across the top of the shield. The text "Page 4 of 7" is located at the top of the image. There is a registered trademark symbol at the bottom right of the shield.
Table 5-1. Comparison of the Ranfac FLEX BMA Needle with the Predicate Ranfac Marrow Cellution Needle
7
Image /page/7/Picture/2 description: The image shows the Ranfac logo and the text "Page 5 of 7". The logo is a shield shape with the word "Ranfac" written in a teal color. The shield is divided into two halves, with the left half being a light brown color and the right half being white. The text "Page 5 of 7" is located at the top of the image.
The subject and primary predicate device differ from one another primarily with respect to gauge size (increase diameter to 8 gauge), aspiration cannula configuration (flexible vs. rigid Aspirator Cannula tip) and inclusion of an exchangeable drill insert. To bridge these differences in product characteristics between the subject FLEX Needle and primary predicate, the following reference predicates have been cited:
8
Image /page/8/Picture/2 description: The image shows the text "Page 6 of 7" at the top, indicating it is a page number within a document. Below the page number is the word "Ranfac" in a stylized font, with the "R" being larger and a different color than the rest of the word. To the left of the word "Ranfac" is a semi-circular graphic that is shaded in a gradient from light to dark. There is also a registered trademark symbol at the bottom of the image.
-
For 8 gauge needle: Ranfac Bone Marrow Biopsy Needle K190177, cleared June 12, 2019
-
For flexible shaft: MarrowMiner: K071732, cleared September 24, 2007
- A Exchangeable drill insert: Oncontrol Bone Marrow Biopsy System K072045, cleared October 22, 2007
Performance Data
Structural integrity testing was conducted on the Ranfac FLEX BMA Needle demonstrating robustness and appropriateness of the design. All samples met or exceeded acceptance criteria. Strength specifications are similar to those of the predicate Ranfac Marrow Cellution Bone Marrow Aspiration Needle. Additionally, simulated use and cadaver testing was performed to validate that the design output of the Ranfac FLEX BMA Needle met design input requirements.
Biocompatibility Testing
A biocompatibility evaluation was conducted in accordance with the FDA Guidance Document Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process," consistent with the requirements for an externally communicating device (with tissue) for a limited duration (≤24 hours). The following biocompatibility tests were successfully completed on the final, sterilized Ranfac FLEX BMA Needle:
- o Cytotoxicity
- Sensitization ●
- Irritation or Intracutaneous toxicity
- Acute Systemic Toxicity
- Material-Mediated Pyrogenicity
Sterility
The Ranfac FLEX BMA Needle is sterilized via a validated ethylene oxide (EO) process to a Sterility Assurance Level (SAL) of 10-6. The sterilization process was validated per ISO 11135 Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices.
Shelf Life
The Ranfac FLEX BMA Needle has a shelf life of 6-months. Shelf life studies have been conducted to demonstrate that the device maintains its performance and the packaging will maintain its sterile barrier over the entirety of the intended shelf life.
9
Traditional 510(k) – Ranfac Flex Bone Marrow Aspiration Needle Ranfac Corp.
Image /page/9/Picture/2 description: The image shows the text "Page 7 of 7" at the top, indicating it is the last page of a document. Below the page number is the Ranfac logo, which is a stylized design with the company name in a distinctive font. The logo also includes a curved shape, partially filled with a light color, adding a visual element to the brand identity. The presence of the registered trademark symbol suggests the brand is legally protected.
Clinical Performance Data
No clinical studies were deemed necessary to demonstrate the safety and effectiveness of the subject device.
Conclusion
Ranfac has demonstrated that the Ranfac FLEX BMA Needle is substantially equivalent in fundamental design, function, device materials, packaging, sterilization, operating principle, intended use/ indication for use and fundamental technology as the legally marketed predicate device Ranfac Marrow Cellution Needle, which was cleared under Premarket Notification K150563 on May 22, 2015.