The Ranfac Bone Marrow Biopsy Needles subject of this premarket notification (RTN-114, RTN-116, RTN-84, RTN-86, RTN-114-T, RTN 116-T, RTN-84-T, RTN-86-T, RJN -114, RJN -116, RJN-84, RJN-86) are manual, sterile disposable needles intended for the purpose of harvesting bone marrow specimens. The device is comprised of an outer cannula with handle and an inner stylet. The cannula has graduated etched markings spaced in 1 cm intervals. The product is provided with a probe guide and marked probe to assist with the extraction of the bone marrow specimen from the needle. The probe guide facilitates the insertion of the marked probe through the distal end of the needle. The marked probe is introduced into the probe guide at the distal tip of the needle and advanced forward to move and expel the specimen out through the needle handle. Specific models of the Ranfac Bone Marrow Biopsy Needles are also provided with a stainless steel marrow extraction cannula (either Canoe or Tweezer design) which fit inside the needle to facilitate capture and retrieval of bone marrow samples. The specimen is contained within the extraction cannula during withdrawal from the needle. The Ranfac Bone Marrow Biopsy Needles are provided with a luer cap to prevent back flow of blood during needle insertion and product with the optional extraction cannula are provided with two needle vices to cap the needle and stylet tip prior to disposal.

AI/ML Overview

I am unable to provide the details you requested regarding acceptance criteria and study data for the device. The provided text is an FDA 510(k) clearance letter for Ranfac Bone Marrow Biopsy Needles, not a study report or clinical trial summary.

While the document states that "Performance testing and comparison of characteristics between the subject and predicate devices have demonstrated that the Ranfac Bone Marrow Biopsy Needles are substantially equivalent to the predicate devices...", it does not include specific acceptance criteria, detailed performance data, sample sizes, information on ground truth establishment, or any of the other specific study parameters you requested.

The document only generally mentions:

Biocompatibility Testing: Passing results for Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic toxicity, and Material-Mediated Pyrogenicity.
Bench Testing:
- Structural integrity testing (tensile/torque) with all samples meeting or exceeding acceptance criteria.
- Comparative performance testing using the Jamshidi Bone Marrow Biopsy/Aspiration Needle demonstrating suitability for bone marrow sampling.
- Simulated use testing to validate design output met design input requirements.
Clinical Studies: "No clinical studies were conducted for this submission."

Therefore, I cannot extract the information required to populate the fields in your request, such as a table of acceptance criteria and reported performance, sample sizes, expert qualifications, or details on ground truth for training or test sets.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 12, 2019

Ranfac Corporation Eric Kreuz Director of Quality Assurance/Regulatory Affairs 30 Doherty Ave Avon, Massachusetts 02322

Re: K190177

Trade/Device Name: Ranfac Bone Marrow Biopsy Needles (J-Type Marrow Biopsy Needle, T-Type Marrow Biopsy Needle, and Tweezer Bone Marrow Biopsy Needle) Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: KNW, FCG Dated: May 9, 2019 Received: May 13, 2019

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

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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 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 (QS) 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 medical devices and radiation-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.

for

Jennifer R. Stevenson Acting Division 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K190177

Device Name Ranfac Bone Marrow Biopsy Needle

Indications for Use (Describe)

The Ranfac Bone Marrow Biopsy Needles are indicated for use in aspirating bone marrow and for use in obtaining core biopsy samples of bone marrow.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

I. SUBMITTER

Sponsor:	Ranfac Corp.30 Doherty Ave.Avon, MA
Contact Person:Date:	Eric KreuzMay 9, 2017Ph: 1-508-584-4400, Ext. 137Fax: 1-508-584-8588

II. DEVICE

Device Trade Name:	Ranfac Bone Marrow Biopsy Needle
Common or Usual Name:	Biopsy Needle
Device Classification:	Class II
Classification Name:	Instrument, Biopsy
Regulation:	876.1075
Device Regulation Panel:	Gastroenterology/Urology
Device Product Code:	KNW & FCG

III. PREDICATE DEVICES

Ranfac Bone Marrow Aspiration Needle (K131157 - primary predicate), Ranfac Goldenberg Bone Marrow Biopsy Needle (K983187) and the CareFusion Jamshidi Bone Marrow Biopsy/Aspiration Needle (K171531).

DEVICE DESCRIPTION IV.

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V. INDICATIONS FOR USE

The Ranfac Bone Marrow Biopsy Needles are intended for use in aspirating bone marrow and for use in obtaining core biopsy samples of bone marrow.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The Ranfac Bone Marrow Biopsy Needles are similar to the predicate Ranfac Needles in intended use (i.e., acquisition of bone marrow), fundamental scientific technology, operating principles, fundamental mechanical design, performance characteristics, packaging, sterility, shelf-life and biocompatibility. The Ranfac Bone Marrow Biopsy Needles and predicate devices share a similar basic design (needle cannula and stylet) and are provided sterile for single use, have the same materials, and operation. A comparison of the Ranfac Bone Marrow Biopsy Needles with the predicate devices is provided in Table 5-1. This table details the closely shared indications for use, materials and design and principle of operation between the devices, therefore establishing substantial equivalence of the devices subject of this current submission with the predicate products.

	Ranfac BoneMarrow BiopsyNeedle(This Submission)	Ranfac BoneMarrowAspiration Needle(K131157)	Goldenberg BoneMarrow BiopsyNeedle (K983187)	JamshidiBone MarrowBiopsy/AspirationNeedle(K171531)
RegulationNumber	21 CFR §876.1075	Same	Same	Same
Intended Use	Intended for use inaspirating bonemarrow and for usein obtainingcylindrical corebiopsy samples ofbone marrow	Intended for use inaspirating bonemarrow	Intended for use inobtainingcylindrical corebiopsy samples ofbone marrow	Intended for use inaspirating bonemarrow and for usein obtainingcylindrical corebiopsy samples ofbone marrow
Indication for Use	The Ranfac BoneMarrow BiopsyNeedles areindicated for use inaspirating bonemarrow and for usein obtaining corebiopsy samples ofbone marrow.	The Ranfac BoneMarrow AspirationNeedle is intendedfor use inaspirating bonemarrow	For procuring bonemarrow corebiopsies frompatients withhematologicabnormalities.	Intended for theposterior iliac crestbiopsy technique.

Table 5-1. Comparison of the Ranfac Bone Marrow Biopsy Needle to the Primary and Secondary Predicate Bone Marrow Biopsy Needles

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	Ranfac BoneMarrow BiopsyNeedle(This Submission)	Ranfac BoneMarrowAspiration Needle(K131157)	GoldenbergBone MarrowBiopsy Needle(K983187)	JamshidiBone MarrowBiopsy/AspirationNeedle(K171531)
Overall ProductDesign	Single-use, steriledisposable needle toacquire tissuespecimen. Thedevice is comprisedof an outer cannulawith handle and aninner stylet.	Same	Same	Same
Mechanics ofOperation	Manual instrument	Manual Instrument	ManualInstrument	Manual Instrument
Patient/TissueContact Materials	Stainless steel andplastic	Stainless steel andplastic	Stainless steel andplastic	Stainless steel andplastic
Gauge x Length	8 and 11 Gauge inlengths of 4 and 6inches	11 Gauge x 4inches	11 Gauge x 4inches	8 and 11 Gauge x 4and 6 inches
CannulaConfiguration	304 stainless steelhollow cannula withno side ports	304 stainless steelhollow cannulawith side ports	316L stainlesssteel with internalpolyurethanemolded spiralsnare	Stainless steel hollowcannula with multiplecutting edges and noside ports
StyletConfiguration	Solid stainless-steelwire	Same	Same	Same
HandleConfiguration	"T-Style" matingplastic handle oncannula and stylet	"T-Style" matingplastic handle oncannula and stylet	"T-Style" matingaluminum handleon cannula andthreaded retainerknob on stylet	Mating plastic handleon cannula
Needle CuttingTip Configuration	Beveled SwagedNeedle Tip	5-point Needle Tip	5-point NeedleTip	Beveled SwagedNeedle Tip

Table 5-1. Comparison of the Ranfac Bone Marrow Biopsy Needle to the Primary and Secondary Predicate Bone Marrow Biopsy Needles

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	Ranfac BoneMarrow BiopsyNeedle(This Submission)	Ranfac BoneMarrowAspiration Needle(K131157)	GoldenbergBone MarrowBiopsy Needle(K983187)	JamshidiBone MarrowBiopsy/AspirationNeedle(K171531)
Bone MarrowExtractionAccessories	Probe guide andprobe provided toexpel tissuespecimen fromneedle cannula –Tweezer and CanoeExtraction Cannulaoptionally provided	None: tissue isaspirated throughneedle usingstandardhypodermicsyringe.	Spiral snareinternal to needleis used to captureand retain tissue	Probe guide andprobe provided toexpel tissue specimenfrom needle cannula– some versions ofthe Jamshidi needleare provided with aspecimen cradlewhich is a componentsimilar to theextraction cannulasprovided with theRanfac needle.
Packaging	Tyvek/Mylar Pouch	Tyvek/MylarPouch	Tyvek/MylarPouch	Tyvek/Mylar Pouch
Sterilization	Supplied sterile viaEthylene Oxidevalidated to 10-6Sterility AssuranceLevel	Same	Same	Supplied sterile viaGamma irradiation
Shelf-Life	5 years	5 years	Not stated inK983187	5 years

Table 5-1. Comparison of the Ranfac Bone Marrow Biopsy Needle to the Primary and Secondary Predicate Bone Marrow Biopsy Needles

The differences between the Ranfac Bone Marrow Biopsy Needles and predicate Ranfac Bone Marrow Aspiration Needle include the addition of the 8 gauge and 6 inch length needles, as well as the addition of the bone marrow extraction accessories; i.e., probe guide, marked probes and extraction cannula used to facilitate retrieval of a trephine biopsy. These changes have been incorporated to adapt for user preferences. Additionally, the Ranfac Bone Marrow Biopsy Needle has a swaged needle tip vs. a 5-point tip configuration to facilitate coring of bone. The predicate Jamshidi Bone Marrow Biopsy/Aspiration Needles (reference K171531) classified under 21 CFR §876.1075 (procode KNW) is provided in sizes of 8 and 11 gauge, lengths of 4 and 6 inch, with swaged needle tip and with an extraction cannula (referred to as a marrow acquisition or "specimen" cradle) and probe for retrieving and expelling the tissue sample.

Similar to the Ranfac Goldenberg Bone Marrow Biopsy and Jamshidi Bone Marrow Biopsy/Aspiration Needles, the needles subject of this 510k are used to obtain a trephine biopsy (i.e., "core-type" biopsy"); whereas, the predicate Ranfac Bone Marrow Aspiration Needle has side holes on the needle cannula to allow for bone marrow acquisition via aspiration. Both types of tissue samples (trephine core biopsy and aspirate) are important to the diagnosis of hematological disorders. The general procedures and guidelines in the Ranfac Bone Marrow Biopsy Needle labeling provide instructions for biopsy sample collection.

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Page 5 of 5

In summary, the changes were appropriately assessed through risk analysis activities and do not raise any new or significant questions of safety or effectiveness. The Ranfac Bone Marrow Biopsy Needles are substantially equivalent to the predicate devices presented.

VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility Testing:

The Ranfac Bone Marrow Biopsy Needle has been demonstrated to be biocompatible with passing results for the following testing:

. Cytotoxicity
Sensitization
. Intracutaneous Reactivity
Acute Systemic toxicity
Material-Mediated Pyrogenicity

The Ranfac Bone Marrow Biopsy Needles are considered tissue contacting for a duration of less than 24 hours.

Bench Testing:

Structural integrity testing (tensile/torque) was conducted on the Ranfac Bone Marrow Biopsv Needles demonstrating robustness and appropriateness of the design. All samples met or exceeded acceptance criteria. Testing was consistent with methods used for the predicate Ranfac Bone Marrow Aspiration Needle. Comparative performance testing using the Jamshidi Bone Marrow Biopsy/Aspiration Needle for reference demonstrates that the Ranfac Bone Marrow Biopsy Needle are suitably designed for bone marrow sampling. Additionally, simulated use testing was performed to validate that the design output of the Ranfac Bone Marrow Biopsy Needles met design input requirements.

Clinical Studies:

No clinical studies were conducted for this submission.

VIII. CONCLUSION

Performance testing and comparison of characteristics between the subject and predicate devices have demonstrated that the Ranfac Bone Marrow Biopsy Needles are substantially equivalent to the predicate devices with regard to intended use (harvest of a bone marrow specimen), operation, function, and technological characteristics, all devices being manually operated to obtain a bone marrow specimen.

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.