(78 days)
Not Found
No
The device description details a manual, mechanical needle for bone marrow aspiration and does not mention any computational or algorithmic components.
No
This device is for aspiration of bone marrow or autologous blood, which is a diagnostic or collection procedure, not a therapeutic treatment.
No
The device is intended for the aspiration of bone marrow or autologous blood, which is a collection process, not a diagnostic one. While the collected samples may be used for diagnosis, the device itself performs the collection, not the diagnosis.
No
The device description clearly details a physical needle and cannula system, including materials, dimensions, and mechanical features for bone marrow aspiration. It is a hardware 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 bone marrow or blood. It's a tool for sample collection.
- Lack of Diagnostic Function: The description does not mention any function related to analyzing the collected sample, detecting substances within the sample, or providing diagnostic information based on the sample. IVD devices are designed to perform tests on samples taken from the body to diagnose diseases or conditions.
This device is a medical device used 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 Lateral Access Bone Marrow Aspiration Needle is intended for use 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 Lateral Access 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 comprised of a 7-gauge outer cannula and an 11-gauge inner cannula with an overall length of 6.5 inches when the inner cannula is fully extended. The outer cannula has an adjustable grip, and a blunt tip that rests on the surface of the bone. The inner cannula has a ground point for bone/bone marrow penetration and side ports for marrow aspiration. When the molded grip of the Access Needle is turned clockwise the inner cannula is withdrawn into the outer cannula exposing the tip to a different location within the needle tract allowing for additional bone marrow aspiration acquisition without having to reposition the needle.
During use, the Access Needle is inserted into bone with the aid of a sharp or drillable stylet. Once the needle is properly positioned and the stylet removed, a 14-gauge Aspiration Cannula is inserted into the Access Needle. 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). A white indicator on both the Access Needle and the Aspiration Cannula is provided in order to allow for alignment of the two components' side ports (for aspiration of bone marrow).
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 also packaged with a commercially available, 510k cleared standard 10mL luer lock hypodermic syringe for collection of bone marrow aspirate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 LA BMA Needle demonstrating robustness and appropriateness of the design. All samples met or exceeded acceptance criteria. Strength specifications (resistance to breakage and torque) are similar to those of the predicate Ranfac Marrow Cellution Bone Marrow Aspiration Needle. Additionally, simulated use testing was performed to validate that the design output of the Ranfac LA BMA Needle met design input requirements.
The Ranfac LA BMA Needle is provided sterilized with ethylene oxide to an assurance level of 10th in a validated cycle. Distribution simulation and 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.
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.
Not Found
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, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
February 21, 2023
Ranfac Corporation Eric Kreuz Vice President/Quality & Regulatory Affairs 30 Doherty Avenue Avon, Massachusetts 02322
Re: K223612
Trade/Device Name: Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA) Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: KNW Dated: January 25, 2023 Received: January 25, 2023
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 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
1
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 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.
Mark Digitally signed by Mark Trumbore -S Trumbore - Date: 2023.02.21 S On behalf of 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
Submission Number (if known)
Device Name
Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)
Indications for Use (Describe)
The Lateral Access Bone Marrow Aspiration Needle is intended for use 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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3
Image /page/3/Picture/1 description: The image shows the logo for Ranfac. The logo is a shield shape with the left half filled with a gold gradient and the right half is white. Above the shield is the word "Ranfac" in a blue sans-serif font with a blue line above it.
510(k) Summary
The following information is provided as required by 21 CFR § 807.87 for Ranfac Lateral Access Bone Marrow Aspiration Needle 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the information upon which the substantial equivalence determination is based.
1. SUBMITTER
| Sponsor: | Ranfac Corp.
30 Doherty Ave
Avon, MA |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Eric Kreuz
Vice President/Regulatory & Quality
Ph: 1-508-584-4400, Ext. 137
Fax: 1-508-584-8588
Email: ekreuz@ranfac.com |
| Date: | December 3, 2022 |
2. DEVICE
| Device Proprietary Name: | Ranfac Lateral Access (LA) Bone Marrow Aspiration
Needle |
|----------------------------|-------------------------------------------------------------|
| Common or Usual Name: | Biopsy Needle |
| Regulatory Classification: | Class II |
| Classification Name: | Instrument, biopsy |
| Regulation: | 21 CFR 876.1075 |
| Device Regulation Panel: | Gastroenterology/Urology |
| Device Product Code: | KNW |
3. PREDICATE DEVICE
| Proprietary Name: | Ranfac Marrow Cellution Needle (K150563) |
|---|---|
| Common Name: | Biopsy Needle |
| Classification Name: | Instrument, Biopsy |
| Regulation: | 21 CFR 876.1075 |
| Product Code: | KNW |
| Regulatory Classification: | Class II |
| Classification Panel: | Gastroenterology/Urology |
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Special 510(k) - Ranfac Lateral Access Bone Marrow Aspiration Needle Ranfac Corp. 510(k) Summary - K223612
Image /page/4/Picture/1 description: The image shows the Ranfac logo. The logo is a shield shape that is divided into two halves. The left half of the shield is a gradient of gold, while the right half is white. Above the shield is a horizontal blue line, and above that is the word "Ranfac" in blue text. There is a registered trademark symbol in the bottom right corner of the shield.
4. DEVICE DESCRIPTION
The Ranfac Lateral Access 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 comprised of a 7-gauge outer cannula and an 11-gauge inner cannula with an overall length of 6.5 inches when the inner cannula is fully extended. The outer cannula has an adjustable grip, and a blunt tip that rests on the surface of the bone. The inner cannula has a ground point for bone/bone marrow penetration and side ports for marrow aspiration. When the molded grip of the Access Needle is turned clockwise the inner cannula is withdrawn into the outer cannula exposing the tip to a different location within the needle tract allowing for additional bone marrow aspiration acquisition without having to reposition the needle.
During use, the Access Needle is inserted into bone with the aid of a sharp or drillable stylet. Once the needle is properly positioned and the stylet removed, a 14-gauge Aspiration Cannula is inserted into the Access Needle. 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). A white indicator on both the Access Needle and the Aspiration Cannula is provided in order to allow for alignment of the two components' side ports (for aspiration of bone marrow).
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 also packaged with a commercially available, 510k cleared standard 10mL luer lock hypodermic syringe for collection of bone marrow aspirate.
ட். INDICATIONS FOR USE
The Ranfac Lateral Access BMA Needle is for use for aspiration of bone marrow or autologous blood using a standard piston syringe.
6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH 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 (K150563). The table below summarizes the similarities and differences in design, materials and dimensions between the subject and predicate device.
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Image /page/5/Picture/1 description: The image shows the logo for Ranfac. The logo is a shield shape with the word "Ranfac" in teal at the top right. The shield is divided vertically, with the left side being a textured gold color and the right side being white. There is a registered trademark symbol at the bottom of the shield.
| Table 1. Comparison of the Ranfac LA BMA Needle Technological Characteristics with |
|---|
| Predicate Ranfac Marrow Cellution Needle |
| | Ranfac LA 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. |
| 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. | Single-use, sterile disposable needle to acquire tissue specimen. |
| Mechanics of
Operation | Manual instrument | Manual instrument |
| Patient/Tissue
Contact
Materials | Stainless steel and plastic | Stainless steel and plastic |
| Access Needle
Gauge and
Length | Adjustable length between 4.8 and 6.5 inches. | Needle provided in lengths of 4 and 6 inches. |
| 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. |
| Aspiration
Cannula
Configuration | 14-gauge 304 stainless steel hollow cannula with one set of side ports and ABS luer. | 14-gauge 304 stainless steel hollow cannula with one set of side ports and ABS luer. |
| Aspiration
Cannula Length | 11.5 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 |
| 10mL
Hypodermic
Syringe Provided | Yes | Yes |
| Packaging | Tyvek/Mylar Pouch | Tyvek/Mylar Pouch |
| | Ranfac LA BMA Needle
(This Submission) | Marrow Cellution (K150563) |
| 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 |
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Image /page/6/Picture/1 description: The image shows the Ranfac logo. The logo features the word "Ranfac" in a teal sans-serif font, positioned above a stylized shield. The shield is divided vertically, with the left half being a textured gold color and the right half being white. A thin teal line is above the shield.
Table 1. Comparison of the Ranfac LA BMA Needle Technological Characteristics with Predicate Ranfac Marrow Cellution Needle
7. PERFORMANCE TESTING
Structural integrity testing was conducted on the Ranfac LA BMA Needle demonstrating robustness and appropriateness of the design. All samples met or exceeded acceptance criteria. Strength specifications (resistance to breakage and torque) are similar to those of the predicate Ranfac Marrow Cellution Bone Marrow Aspiration Needle. Additionally, simulated use testing was performed to validate that the design output of the Ranfac LA BMA Needle met design input requirements.
The Ranfac LA BMA Needle is provided sterilized with ethylene oxide to an assurance level of 10th in a validated cycle. Distribution simulation and 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.
Conclusion
Ranfac has demonstrated that the Ranfac LA 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.