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stop for control of needle penetration depth and when turned counterclockwise allows for the Aspiration Cannula to be withdrawn backwards through the bone marrow needle tract in a controlled manner (as opposed to manually pulling back the needle or Aspiration Cannula).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.

AI/ML Overview

The provided text describes the 510(k) submission for the Ranfac FLEX BMA Needle, asserting its substantial equivalence to a predicate device. However, this submission does not contain information about a study that assesses AI/algorithm performance or human reader performance with AI assistance.

Therefore, I cannot fill in the table or provide details for most of the requested points related to AI/algorithm performance, multi-reader multi-case studies, or the specifics of training and test sets and their ground truth.

The document focuses on demonstrating the device's physical and functional equivalence through engineering and biological testing, not through clinical performance data relevant to AI model validation.

Here's a breakdown of what can be extracted from the document based on your request, and where information is missing:

Acceptance Criteria and Device Performance (as far as applicable to this document)

Acceptance Criteria Category	Reported Device Performance (as described in the document)
Structural Integrity	All samples met or exceeded acceptance criteria, demonstrating robustness and appropriateness of the design. Strength specifications are similar to the predicate device.
Simulated Use and Cadaver Testing	Performed to validate that the design output met design input requirements. (Specific quantitative results not provided).
Biocompatibility	Successfully completed tests: Cytotoxicity, Sensitization, Irritation or Intracutaneous toxicity, Acute Systemic Toxicity, Material-Mediated Pyrogenicity.
Sterility	Sterilized via a validated ethylene oxide (EO) process to a Sterility Assurance Level (SAL) of 10-6, validated per ISO 11135.
Shelf-Life	Demonstrated that the device maintains its performance and the packaging maintains its sterile barrier over 6 months.
Clinical Performance (re: device safety/effectiveness)	No clinical studies were deemed necessary to demonstrate safety and effectiveness. (This is relevant to the physical device, not an AI component).
AI/Algorithm Performance Metrics (e.g., Sensitivity, Specificity, AUC)	Not applicable. This document is for a physical medical device (a bone marrow aspiration needle) and does not concern an AI/algorithm.
Human Reader Performance (e.g., accuracy, efficiency)	Not applicable. This document is for a physical medical device (a bone marrow aspiration needle) and does not concern human reader performance with or without AI.

Detailed Study Information (Based on Document Content)

This document describes the 510(k) submission for a physical medical device (a bone marrow aspiration needle), not an AI-powered diagnostic or assistive tool. Therefore, most of the requested information, which pertains to AI/algorithm development and validation, is not present in the provided text.

Sample size used for the test set and data provenance:
- Not applicable for AI/algorithm testing. The document mentions "Structural integrity testing," "simulated use and cadaver testing," "biocompatibility testing," "sterility validation," and "shelf life studies." Specific sample sizes for these engineering and biological tests are not detailed beyond "All samples" for structural integrity.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable for AI/algorithm testing. Ground truth, in the context of an AI model, typically refers to expert labels on a dataset. This concept does not apply to the validation of a physical medical device as described here.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable for AI/algorithm testing. Adjudication is a process to resolve disagreements among human labelers, which is not relevant to the physical device validation described.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. Not applicable. This document pertains to clearances for a physical device, not an AI system that assists human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a manual, physical instrument. There is no algorithm to test in standalone mode.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable for AI/algorithm testing. For the physical device, "ground truth" would be the success of a mechanical test, sterility validation result, or biocompatibility outcome. These are defined by established standards (e.g., ISO 11135 for sterility).
The sample size for the training set:
- Not applicable for AI/algorithm training. There is no AI model being trained for this physical device.
How the ground truth for the training set was established:
- Not applicable for AI/algorithm training. There is no AI model being trained for this physical device.

Summary: The provided FDA 510(k) submission describes the substantial equivalence of a physical medical device (bone marrow aspiration needle) to a predicate device. The performance data shared relates to the manufacturing, material, and mechanical properties of the needle, and does not involve AI algorithms or human reader performance studies. Therefore, most of the requested details concerning acceptance criteria and studies for AI-based devices cannot be extracted from this document.

Summary

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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

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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

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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)

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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

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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 BoneMarrow BiopsyNeedle	MarrowMiner	OnControl BoneMarrow AspirationSystem
Manufacturer:	Ranfac	StemCor Systems,Inc.	VidaCare Corp. (nowTeleflex)
510(k) Number:	K190177	K071732	K072045
Device Common Name:	Biopsy Needle	Biopsy Instrument	Biopsy Needle
Classification:	Biopsy Instrument/ Class II per§876.1075 /ProcodeKNW/FCG	Biopsy Instrument /Class II per§878.4820 /Procode GDM/GAA	Biopsy Instrument /Class II per§876.1075 / ProcodeKNW/FCG
Classification Panel:	Gastroenterology/ Urology	General & PlasticSurgery	Gastroenterology /Urology
Reason for ReferencePredicate	To cover thecharacteristic foran 8 gauge needle	To cover the flexibleshaft	To cover attribute foran exchangeable drillinsert

Device Description:

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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)
RegulationNumber	21 CFR §876.1075	21 CFR §876.1075
Intended Use	For harvest of bone marrowtissue	For harvest of bone marrowtissue
Indication for Use	For use for aspiration of bonemarrow or autologous bloodusing a standard pistonsyringe.	For use for aspiration of bonemarrow or autologous bloodusing a standard piston syringe.
Ranfac Marrow Cellution Needle
	FLEX BMA Needle(This Submission)	Marrow Cellution (K150563)
PerformanceCharacteristics	Needle bores into bone toaccess marrow cavity	Needle bores into bone toaccess marrow cavity
Overall ProductDesign	Single-use, sterile disposableneedle to acquire tissuespecimen. The device iscomprised of an outer cannulawith handle and an inner styletand Aspiration Cannula withflexible stainless steel coiltubing tip. Includes an integralthreaded Adjustable Guidethat when turned counter-clockwise allows for theaspiration cannula to bewithdrawn backwards throughthe marrow (rather thanmanually pulling back on theaspiration cannula). Needlehas depth markings everycentimeter.	Single-use, sterile disposableneedle to acquire tissuespecimen. The device iscomprised of an outer cannulawith handle and an inner styletand an Aspiration Cannula withrigid stainless steel tip. Includesan integral threaded AdjustableGuide that when turnedcounter-clockwise allows for theneedle to be withdrawnbackwards through the marrow(rather than manually pullingback on the needle). Needle hasdepth markings everycentimeter.
Mechanics ofOperation	Manual instrument	Manual instrument
Patient/TissueContactMaterials	Stainless steel and plastic	Stainless steel and plastic
Access NeedleGauge x Length	8 gauge by 3 inch 304 stainlesssteel needle with cm etcheddepth markings and ABS T-Handle	11 Gauge by 4 or 6 inch 304stainless steel needle with cmetched depth markings and ABST-Handle
Needle CuttingTip Configuration	Stylet has beveled 3-sidedtrocar tip and needle cannulahas 5-sided grind tip forpenetration	Stylet has beveled 3-sided trocartip and needle cannula has 5-sided grind tip for penetration –also provided with blunt tipstylet
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)
AspirationCannulaConfiguration	11 gauge 316L stainless steelhollow cannula with weldedflexible 316L stainless steeldistal end. The very distal endof the cannula is closed withside ports for aspiration.Provided with ABS luer andsnap fit T-handle. Providedwith Stylet.	14 gauge x 304 stainless steelhollow cannula with one set ofside ports and ABS luer.
AspirationCannula WorkingLength	9.8 inches nominal	9.2 inches nominal
HandleConfiguration	T-Shaped Handle Configuration	T-Shaped Handle Configuration
Adjustable DepthGuide	Yes	Yes
Drillable Stylet	Yes	No
Packaging	Components in PETG trayplaced in Tyvek/Mylar Pouch	Tyvek/Mylar Pouch
Sterilization	Supplied Sterile via EthyleneOxide validated to 10-6 SterilityAssurance Level	Supplied Sterile via EthyleneOxide validated to 10-6 SterilityAssurance Level
Shelf-Life	6 months	5 years

Table 5-1. Comparison of the Ranfac FLEX BMA Needle with the Predicate Ranfac Marrow Cellution Needle

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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

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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:

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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.

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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.

Regulation Number and Section

§ 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.