(154 days)
The ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) is indicated for aspiration of bone marrow or autologous blood.
The ALARA BMA Neuro Access Kit is indicated for pedicle pilot hole preparation, locating, and identifying spinal roots / nerves by providing proximity feedback.
The ALARA BMA Neuro Access Kit utilizes a neuromonitoring platform in providing the surgeon with nerve / root location feedback during the approach to a pedicle to support a guidewire placement.
The ALARA BMAN and ALARA BMAC Kit includes various single-use needles designed for bone marrow aspiration and aspiration of autologous blood.
The provided text describes the regulatory clearance of the ALARA BMA Neuro Access Kit, focusing on its substantial equivalence to predicate devices based on design, materials, and non-clinical testing. However, it does not include acceptance criteria, reported device performance, or details of a study that proves the device meets specific performance criteria.
Therefore, I cannot populate the table or answer questions 2 through 9 based on the provided document. The document primarily focuses on regulatory approval based on comparison to existing legally marketed devices, rather than a detailed performance study against predefined acceptance criteria.
{0}------------------------------------------------
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 and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
August 9, 2024
SurGenTec, LLC % Mr. Michael Coladonato Associate Director, Regulatory Affairs MCRA. LLC 803 7th Street NW Washington DC 20001
Re: K240664
Trade/Device Name: ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology-Biopsy Instrument Regulatory Class: Class II Product Code: KNW, PDQ Dated: May 30, 2024 Received: May 30, 2024
Dear Mr. Michael Coladonato:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
{1}------------------------------------------------
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 H. Chen -S = Digitally signed by Long H.Chen-S
Date: 2024.08.09 15:21:26 -04'00'
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
510(k) Number (if known) K240664
Device Name
ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)
Indications for Use (Describe)
The ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) is indicated for aspiration of bone marrow or autologous blood.
The ALARA BMA Neuro Access Kit is indicated for pedicle pilot hole preparation, locating, and identifying spinal roots / nerves by providing proximity feedback.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) Summary
| Submitter: | SurGenTec, LLC911 Clint Moore RdBoca Raton, FL 33487 |
|---|---|
| Official Correspondent: | Mr. Michael ColadonatoAssociate Director, Regulatory AffairsMCRA, LLC803 7th Street NWWashington DC 20001202-552-5800mcoladonato@mcra.com |
| Date Prepared: | August 9, 2024 |
| Trade Name: | ALARA BMA Neuro Access Kit (ALARA BMAN and ALARABMAC Kit) |
| Common Name: | Aspiration Needle, BMA Needle |
| Classification: | 21 CFR 876.1075, 21 CFR 874.1820 |
| Product Code: | KNW, PDQ |
| Primary Predicate: | Ranfac Bone Marrow Aspiration Needle, Ranfac Corp. (K131157) |
| Additional Predicate: | ALARA Neuro Access Kit, SurGenTec LLC (K190163) |
Device Description:
The ALARA BMA Neuro Access Kit utilizes a neuromonitoring platform in providing the surgeon with nerve / root location feedback during the approach to a pedicle to support a guidewire placement.
The ALARA BMAN and ALARA BMAC Kit includes various single-use needles designed for bone marrow aspiration and aspiration of autologous blood.
Indications for Use:
The ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) is indicated for aspiration of bone marrow or autologous blood.
The ALARA BMA Neuro Access Kit is indicated for pedicle pilot hole preparation, locating, and identifying spinal roots / nerves by providing proximity feedback.
{4}------------------------------------------------
Substantial Equivalence:
The ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) is substantially equivalent to the predicate device.
| Information | Subject Device | Primary Predicate | Secondary predicate |
|---|---|---|---|
| Trade Name | ALARA BMA Neuro Access Kit(ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC | Ranfac Bone MarrowAspiration NeedleRanfac Corporation | ALARA Neuro Access KitSurGenTec, LLC |
| 510(k) number | SubjectDevice | K131157 | K190163 |
| Regulation | 21 CFR 876.107521 CFR 874.1820 | 21 CFR 876.1075 | 21 CFR 874.1820 |
| Classification | II | II | II |
| Product Code | PDQ, KNW | KNW | PDQ |
| Indications foruse | The ALARA BMA Neuro Access Kit isindicated for pedicle pilot hole preparation,locating, and identifying spinal roots / nervesby providing proximity feedback.The ALARA BMA Neuro Access Kit (ALARABMAN and ALARA BMAC Kit) is indicatedfor aspiration of bone marrow or autologousblood. | The Ranfac Bone MarrowAspiration Needle is intendedfor use in aspirating bonemarrow. | The ALARA Neuro AccessKit is indicated for pediclepilot hole preparation,locating, and identifyingspinal roots / nerves byproviding proximityfeedback. |
| SurgicalApproach | Minimally Invasive | Minimally Invasive | Minimally Invasive |
| Material | Stainless Steel | Stainless Steel | Stainless Steel |
| Diameter | 11 Gauge - 3mm | 8 Gauge, 11 Gauge | 11 Gauge - 3mm |
| Lengths | 12.8cm | 11cm - 15cm | 12.8cm |
| Use of the Needle | Needle depth stop at bone | Needle depth stop at skin | Needle depth stop at bone |
| PackagedSterilized | Yes | Yes | Yes |
| Single Use Device | Yes | Yes | Yes |
The ALARA BMAN and BMAC Kit are similar in materials and design to the predicate device. Both are manufactured from stainless steel and ABS. Both devices include a cannulated version and include similar lengths, and diameters. Both devices have plastic molded handles for the cannula and stylet that mate with each other to prevent separation.
Non-Clinical Data:
The following tests have been performed on the ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit):
- Cannula Handle Torque Test
- Cannula Handle Pull Test
- Stylet Handle Pull Test ●
- Needle Strength from Impaction and Compression Tests
- Luer Lock Verification per ISO 80369
- Needle Particle Aspiration ●
- Needle Cell Viability Test
- Packaging Validation
- Sterilization Validation
{5}------------------------------------------------
- . Biocompatibility Assessment
Conclusion:
Based on the similarities in materials, design, principles of operation, and results of the non-clinical testing, the ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) is substantially equivalent to the predicate device for the requested indications for use.
§ 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.