(163 days)
No
The device description and performance studies focus on the mechanical function and biocompatibility of a manual biopsy needle, with no mention of AI or ML.
No
The device is intended to obtain a sample of tissue for diagnostic purposes, not to treat a condition.
No
The device is intended to obtain a sample of tissue for analysis, not to diagnose a condition directly. It's a tool for biopsy, which is a step towards diagnosis, but not a diagnostic device itself.
No
The device description clearly outlines a physical, manual needle with components like an outer cannula, inner stylet, probe guide, and probe. The performance studies focus on biocompatibility and structural integrity of this physical device. There is no mention of software as a component or function of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "obtain a sample of articular cartilage tissue during arthroscopy." This describes a procedure to collect a biological sample from the body.
- Device Description: The device is a "manual, sterile disposable needle" designed for tissue collection.
- Lack of Diagnostic Function: The description focuses on the mechanics of obtaining the sample. There is no mention of the device being used to analyze the sample, detect substances, or provide any diagnostic information in vitro (outside the body).
IVD devices are used to examine specimens obtained from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is solely to collect the specimen. The subsequent analysis of the collected cartilage tissue would likely involve IVD procedures, but the biopsy needle itself is not an IVD.
N/A
Intended Use / Indications for Use
The Cartilage Biopsy Needle is intended to obtain a sample of articular cartilage tissue during arthroscopy.
Product codes (comma separated list FDA assigned to the subject device)
KNW, FCG
Device Description
The Ranfac Cartilage Biopsy Needle is a manual, sterile disposable needle intended to obtain a sample of cartilage during arthroscopy. The device is comprised of an outer cannula with handle and an inner stylet. The product is provided with probe guide and probe to assist with the extraction of the cartilage from the needle. The probe guide facilitates the insertion of the probe through the distal end of the needle. The 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. This premarket notification is for both an 8-gauge and 11-gauge needle (product catalog numbers: CBN-84 and CBN-114, respectively).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
articular cartilage tissue
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)
Biocompatibility Testing:
The biocompatibility evaluation for the Ranfac CBN was conducted in accordance with FDA's Guidance "Use of International Standard ISO-10993-1, "Biological evaluation of medical devices Part 1: Evaluation and Testing Within a Risk Management Process," as published by FDA on June 16, 2016. The battery of testing included the following tests with passing results for all:
- Cytotoxicity
- Sensitization
- Intracutaneous Reactivity ●
- Acute Systemic toxicity
- Material-Mediated Pyrogenicity ●
The Ranfac CBN is considered tissue contacting for a duration of less than 24 hours.
Bench Testing:
Structural integrity testing (tensile/torque) was conducted on the Ranfac CBN demonstrating robustness of the design. All samples met or exceeded acceptance criteria. Additionally, testing was performed to demonstrate that the Ranfac CBN was suitably designed for its intended purpose; i.e., acquisition of a cartilage biopsy, while maintaining the integrity of the sample as evaluated via histological analysis in a model in which articular cartilage was harvested from ex vivo bovine knees.
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.
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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".
April 25, 2019
Ranfac Corporation Eric Kreuz Director of Quality Assurance/Regulatory Affairs 30 Doherty Ave Avon, Massachusetts 02322
Re: K183146
Trade/Device Name: Ranfac Cartilage Biopsy Needle Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: KNW, FCG Dated: November 8, 2018 Received: November 13, 2018
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Image /page/1/Picture/5 description: The image shows a digital signature. The signature is from Long H. Chen -S. The date of the signature is 2019.04.25 at 06:21:18, with a time zone of -04'00'. The signature is for an unspecified purpose.
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183146
Device Name Ranfac Cartilage Biopsy Needle
Indications for Use (Describe)
The Cartilage Biopsy Needle is intended to obtain a sample of articular cartilage tissue during arthroscopy.
| 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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Page 1 of 4
510(k) Summary
I. SUBMITTER
| Sponsor: | Ranfac Corp.
30 Doherty Ave
Avon, MA |
|-----------------|-----------------------------------------------------------------------|
| Contact Person: | Eric Kreuz |
| Date: | March 23, 2019
Ph: 1-508-588-4400, Ext. 137
Fax: 1-508-584-8588 |
II. DEVICE
| Device Trade Name: | Ranfac Cartilage 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). This device has not been subject to a design-related recall.
A reference predicate for this device is the CareFusion Jamshidi-Type Bone Marrow Biopsy/Aspiration Needle (K171531).
IV. DEVICE DESCRIPTION
The Ranfac Cartilage Biopsy Needle is a manual, sterile disposable needle intended to obtain a sample of cartilage during arthroscopy. The device is comprised of an outer cannula with handle and an inner stylet. The product is provided with probe guide and probe to assist with the extraction of the cartilage from the needle. The probe guide facilitates the insertion of the probe through the distal end of the needle. The 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. This premarket notification is for both an 8-gauge and 11-gauge needle (product catalog numbers: CBN-84 and CBN-114, respectively).
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Page 2 of 4
INDICATIONS FOR USE V.
The Cartilage Biopsy Needle is intended to obtain a sample of articular cartilage tissue during arthroscopy.
The Indications for Use statement for the Cartilage Biopsy Needle is not identical to the predicate device which is used for obtaining a sample of bone marrow; however, the differences do not alter the high-level intended use of the device nor do they affect the safety and effectiveness of the device relative to the predicate. Both the subject and predicate devices are used to harvest a tissue specimen near bone.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH VI. THE PREDICATE DEVICE
The Ranfac Cartilage Biopsy Needles ("CBN)" are similar to the predicate Ranfac Bone Marrow Aspiration Needle ("BMA Needle" - K131157) in intended use (i.e., acquisition of tissue), fundamental scientific technology, operating principles, fundamental mechanical design, performance characteristics, packaging, sterility, shelf-life and biocompatibility. The proposed and predicate devices share a similar design (needle cannula and stylet) and are provided sterile for single use, have the same materials, and operate in the Ranfac CBN with the primary predicate Ranfac BMA Needle is provided in Table 5-1. This table details the closely shared indications for use, materials and design and principle of operation therefore establishing substantial equivalence of the proposed device with the presently commercialized predicate product.
| | Ranfac Cartilage Biopsy
Needle (This Submission) | Ranfac Bone Marrow Aspiration
Needle (K131157) |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation
Number | 21 CFR §876.1075 | Same |
| Intended Use
Indication for Use | For harvest of a tissue sample/tissue biopsy
The Ranfac Cartilage Biopsy Needle is
intended to obtain a sample of articular
cartilage tissue during arthroscopy. | Same
The Ranfac Bone Marrow Aspiration
Needle is intended for use in
aspirating bone marrow |
| 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. The device is provided
in two gauge sizes; i.e., 8 gauge (CBN-84)
and 11 gauge (CBN-114). | Single-use, sterile disposable needle to
acquire tissue specimen. The device is
comprised of an outer cannula with
handle and an inner stylet. The device is
an 11-gauge needle. |
| Mechanics of
Operation | Manual instrument | Manual instrument |
| Patient/Tissue
Contact Materials | Stainless steel and plastic | Stainless steel and plastic |
| Gauge x Length | 8 and 11-Gauge x 4 inches | 11 Gauge x 4 inches |
Table 5-1. Comparison of the Proposed Ranfac Cartilage Biopsy Needle to the Primary Predicate Ranfac Bone Marrow Aspiration Needle
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Page 3 of 4
| | Ranfac Cartilage Biopsy Needle
(This Submission) | Ranfac Bone Marrow Aspiration
Needle (K131157) |
|----------------------------------|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Cannula
Configuration | 304 stainless steel hollow cannula with no side
ports | 304 stainless steel hollow cannula
with side ports |
| Stylet
Configuration | Solid stainless-steel wire | Same |
| Handle
Configuration | Mating plastic handle on cannula and stylet | Same |
| Sample Extraction
Accessories | Probe guide and probe provided to expel tissue
specimen from needle cannula | None: tissue is aspirated through
needle using standard hypodermic
syringe. |
| Packaging | Tyvek/Mylar Pouch | Same |
| Sterilization | Supplied Sterile via Ethylene Oxide validated to
10-6 Sterility Assurance Level | Same |
| Shelf-Life | 5 years | 5 years |
| Table 5-1. Comparison of the Proposed Ranfac Cartilage Biopsy Needle to the Primary | ||
|---|---|---|
| Predicate Ranfac Bone Marrow Aspiration Needle |
The differences between the proposed and predicate devices is that the Ranfac CBN is intended for acquisition of cartilage; whereas, the Ranfac BMA needle is used to acquire bone marrow, both bone marrow aspirate and cartilage can be characterized as soft tissues and in both cases the needles must penetrate bone for purposes of acquiring the target tissue. The Ranfac BMA Needle is an 11-gauge needle and includes side-holes for aspiration of the bone marrow; whereas, the Ranfac CBN is provided in an 8 and 11-gauge configuration and without side holes. The Ranfac CBN is provided with a probe to facilitate tissue acquisition. These differences are not unique to the Ranfac CBN. The Jamshidi-type Bone Marrow Biopsy/Aspiration Needles (reference K171531) classified under 21 CFR §876.1075 (procode KNW) is provided in both an 8 gauge and 11-gauge configuration (no side ports on needle cannula), and provided with a probe for expelling the tissue sample. Both the Ranfac CBN and the reference Jamshidi-type needle acquire a solid core of tissue (trephine biopsy) using similar methods. The general procedures and guidelines in the proposed Ranfac CBN device's labeling provide instructions for cartilage biopsy sample collection.
In summary, the proposed changes were appropriately assessed and do not raise any new or significant questions of safety or effectiveness. The proposed device is substantially equivalent to the predicate devices presented.
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
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Page 4 of 4
Biocompatibility Testing:
The biocompatibility evaluation for the Ranfac CBN was conducted in accordance with FDA's Guidance "Use of International Standard ISO-10993-1, "Biological evaluation of medical devices Part 1: Evaluation and Testing Within a Risk Management Process," as published by FDA on June 16, 2016. The battery of testing included the following tests with passing results for all:
- Cytotoxicity
- Sensitization
- Intracutaneous Reactivity ●
- Acute Systemic toxicity
- Material-Mediated Pyrogenicity ●
The Ranfac CBN is considered tissue contacting for a duration of less than 24 hours.
Bench Testing:
Structural integrity testing (tensile/torque) was conducted on the Ranfac CBN demonstrating robustness of the design. All samples met or exceeded acceptance criteria. Additionally, testing was performed to demonstrate that the Ranfac CBN was suitably designed for its intended purpose; i.e., acquisition of a cartilage biopsy, while maintaining the integrity of the sample as evaluated via histological analysis in a model in which articular cartilage was harvested from ex vivo bovine knees.
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 CBN is substantially equivalent to the primary and reference predicate devices with regard to intended use (biopsy for harvest of a tissue specimen), operation, function, and technological characteristics.