(131 days)
No
The device description and performance studies focus on the mechanical aspects and biocompatibility of a manual bone marrow biopsy needle, with no mention of AI or ML.
No
The device is indicated for use in aspirating bone marrow and for obtaining core biopsy samples, which are diagnostic procedures, not therapeutic ones.
No
The device is used to obtain samples (bone marrow biopsy and aspiration) for diagnostic purposes, but it does not perform the diagnostic analysis itself. It is a tool for sample collection, not for diagnosis.
No
The device description clearly outlines physical components such as needles, cannulas, stylets, probe guides, and extraction cannulas, 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 to aspirate bone marrow and obtain core biopsy samples. This is a procedure to collect a biological specimen from the body.
- Device Description: The device is a needle designed for harvesting bone marrow specimens. It's a tool for collecting the sample, not for performing a test on the sample.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease. This device's function is solely to obtain the specimen.
The bone marrow collected by this device could be used for subsequent IVD testing, but the needle itself is a surgical/collection tool, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
KNW, FCG
Device Description
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.
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
Prescription Use
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)
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.
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 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
1
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
2
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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3
510(k) Summary
I. SUBMITTER
| Sponsor: | Ranfac Corp.
30 Doherty Ave.
Avon, MA |
|--------------------------|----------------------------------------------------------------------------------|
| Contact Person:
Date: | Eric Kreuz
May 9, 2017
Ph: 1-508-584-4400, Ext. 137
Fax: 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.
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.
4
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 Bone
Marrow Biopsy
Needle
(This Submission) | Ranfac Bone
Marrow
Aspiration Needle
(K131157) | Goldenberg Bone
Marrow Biopsy
Needle (K983187) | Jamshidi
Bone Marrow
Biopsy/Aspiration
Needle
(K171531) |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Regulation
Number | 21 CFR §876.1075 | Same | Same | Same |
| Intended Use | Intended for use in
aspirating bone
marrow and for use
in obtaining
cylindrical core
biopsy samples of
bone marrow | Intended for use in
aspirating bone
marrow | Intended for use in
obtaining
cylindrical core
biopsy samples of
bone marrow | Intended for use in
aspirating bone
marrow and for use
in obtaining
cylindrical core
biopsy samples of
bone marrow |
| Indication for Use | 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. | The Ranfac Bone
Marrow Aspiration
Needle is intended
for use in
aspirating bone
marrow | For procuring bone
marrow core
biopsies from
patients with
hematologic
abnormalities. | Intended for the
posterior iliac crest
biopsy technique. |
Table 5-1. Comparison of the Ranfac Bone Marrow Biopsy Needle to the Primary and Secondary Predicate Bone Marrow Biopsy Needles
5
| | Ranfac Bone
Marrow Biopsy
Needle
(This Submission) | Ranfac Bone
Marrow
Aspiration Needle
(K131157) | Goldenberg
Bone Marrow
Biopsy Needle
(K983187) | Jamshidi
Bone Marrow
Biopsy/Aspiration
Needle
(K171531) |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| 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. | Same | Same | Same |
| Mechanics of
Operation | Manual instrument | Manual Instrument | Manual
Instrument | Manual Instrument |
| Patient/Tissue
Contact Materials | Stainless steel and
plastic | Stainless steel and
plastic | Stainless steel and
plastic | Stainless steel and
plastic |
| Gauge x Length | 8 and 11 Gauge in
lengths of 4 and 6
inches | 11 Gauge x 4
inches | 11 Gauge x 4
inches | 8 and 11 Gauge x 4
and 6 inches |
| Cannula
Configuration | 304 stainless steel
hollow cannula with
no side ports | 304 stainless steel
hollow cannula
with side ports | 316L stainless
steel with internal
polyurethane
molded spiral
snare | Stainless steel hollow
cannula with multiple
cutting edges and no
side ports |
| Stylet
Configuration | Solid stainless-steel
wire | Same | Same | Same |
| Handle
Configuration | "T-Style" mating
plastic handle on
cannula and stylet | "T-Style" mating
plastic handle on
cannula and stylet | "T-Style" mating
aluminum handle
on cannula and
threaded retainer
knob on stylet | Mating plastic handle
on cannula |
| Needle Cutting
Tip Configuration | Beveled Swaged
Needle Tip | 5-point Needle Tip | 5-point Needle
Tip | Beveled Swaged
Needle Tip |
Table 5-1. Comparison of the Ranfac Bone Marrow Biopsy Needle to the Primary and Secondary Predicate Bone Marrow Biopsy Needles
6
| | Ranfac Bone
Marrow Biopsy
Needle
(This Submission) | Ranfac Bone
Marrow
Aspiration Needle
(K131157) | Goldenberg
Bone Marrow
Biopsy Needle
(K983187) | Jamshidi
Bone Marrow
Biopsy/Aspiration
Needle
(K171531) |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Bone Marrow
Extraction
Accessories | Probe guide and
probe provided to
expel tissue
specimen from
needle cannula –
Tweezer and Canoe
Extraction Cannula
optionally provided | None: tissue is
aspirated through
needle using
standard
hypodermic
syringe. | Spiral snare
internal to needle
is used to capture
and retain tissue | Probe guide and
probe provided to
expel tissue specimen
from needle cannula
– some versions of
the Jamshidi needle
are provided with a
specimen cradle
which is a component
similar to the
extraction cannulas
provided with the
Ranfac needle. |
| Packaging | Tyvek/Mylar Pouch | Tyvek/Mylar
Pouch | Tyvek/Mylar
Pouch | Tyvek/Mylar Pouch |
| Sterilization | Supplied sterile via
Ethylene Oxide
validated to 10-6
Sterility Assurance
Level | Same | Same | Supplied sterile via
Gamma irradiation |
| Shelf-Life | 5 years | 5 years | Not stated in
K983187 | 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.