(57 days)
The Celling Aspiration Needle is intended for use in aspirating bone marrow.
The Celling Aspiration Needle is a single-use aspiration needle comprised of a stainless steel cannula with a molded plastic handle, and a stainless steel stylet with a molded plastic handle which mates with the cannula handle when the stylet is inserted through the cannula. While holding the mated handles, the user rotates the needle using a clockwise-counter clockwise motion while applying pressure on the bone. The needle bores into the marrow cavity. Once there the stylet is removed and aspiration is accomplished by attaching a luer syringe (not included) to the needle and applying negative pressure.
This document is a 510(k) premarket notification for the Celling Aspiration Needle. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of diagnostic performance against acceptance criteria for an AI-powered device. Therefore, much of the requested information regarding AI device performance, sample sizes for training/test sets, ground truth establishment, expert adjudication, and MRMC studies is not applicable or available within this document.
However, I can extract information related to the device's functional performance testing, which is a form of acceptance criteria for this type of medical device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Type of Testing) | Reported Device Performance |
|---|---|
| Mechanical Testing | Performed, supports safety and effectiveness. (Details not provided in this summary, but implied to be acceptable based on SE determination). |
| Physical Testing | Performed, supports safety and effectiveness. (Details not provided). |
| Component Biocompatibility Analysis | Performed, supports safety and effectiveness. (Details not provided). |
| Performance Characteristics | Performed, supports safety and effectiveness. (Details not provided, but implies the device functions as intended for bone marrow aspiration). |
| Substantial Equivalence to Predicate Device (Argon Bone Marrow Harvest Needle, K980196) | The Celling Aspiration Needle is "substantially equivalent" in materials, design (stainless steel cannula/stylet, plastic molded handles, side holes, luer lock connections). The only differences are handle color, needle length, and added depth markings. |
| Equivalence to Secondary Predicate (Ranfac Bone Marrow Aspiration Needle, K131157) | Testing was performed to ensure performance equivalent to the Ranfac needle for current customers. |
| Compliance with FDA Special Controls Guidance (Class II Special Controls Guidance Document for Biopsy Devices in Gastroenterology and Urology) | "meets all of the requirements" of the guidance. |
2. Sample size used for the test set and the data provenance:
- Not applicable for an AI device. This document describes testing for a mechanical bone marrow aspiration needle.
- The "testing" mentioned is non-clinical (mechanical, physical, biocompatibility, performance characteristics) rather than clinical studies with human subjects or retrospective data analysis for a diagnostic algorithm. The specific "sample sizes" for these non-clinical tests (e.g., how many needles were subjected to bending tests, etc.) are not provided in this summary.
- Data provenance is not provided for these engineering tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This relates to algorithmic performance and ground truth for diagnostic accuracy, which is not the focus of this 510(k) for a physical medical device. The "ground truth" for this device's performance would be engineering specifications and functional testing outcomes.
4. Adjudication method for the test set:
- Not applicable. This refers to adjudication in diagnostic studies, not engineering verification and validation testing for a physical device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC study was not done. This is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an AI device.
7. The type of ground truth used:
- For the non-clinical testing of the Celling Aspiration Needle, the "ground truth" would be established engineering specifications, performance standards, biocompatibility testing results (e.g., meeting ISO standards), and direct comparisons to the physical and functional characteristics of the identified predicate devices.
8. The sample size for the training set:
- Not applicable. This device does not use a training set as it is not an AI device.
9. How the ground truth for the training set was established:
- Not applicable. This device does not use a training set.
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May 24, 2018
SpineSmith Holdings, LLC Mr. Clifton Naivar Director, Quality and Regulatory Affairs 4719 S Congress Ave Austin, Texas 78745
Re: K180807
Trade/Device Name: Celling Aspiration Needle Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: KNW Dated: March 23, 2018 Received: March 28, 2018
Dear Mr. Naivar:
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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing, 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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Page 2 - Mr. Clifton Naivar
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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. Jennifer R. Stevenson For 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
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Indications for Use
510(k) Number (if known) K180807
Device Name Celling Aspiration Needle
| Indications for Use (Describe) |
|---|
| -------------------------------- |
The Celling Aspiration Needle is intended for use in aspirating 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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Celling Aspiration Needle
510(k) Summary of Safety and Effectiveness
| SUBMITTED BY | SpineSmith Holdings, LLC4719 S. Congress AveAustin, TX 78745 |
|---|---|
| ESTABLISHMENTREGISTRATION NUMBER | 3006404071 |
| CONTACT PERSON | Clifton (Chris) NaivarDirector - Quality and Regulatory AffairsPhone: 512-637-2068Fax: 512-637-2096Email: cnaivar@spinesmithusa.com |
| SUBMISSION PREPARED BY | Clifton (Chris) NaivarDirector - Quality and Regulatory AffairsPhone: 512-637-2068 |
| DATE PREPARED | March 23, 2018 |
| CLASSIFICATION | Class IIKNW - instrument, biopsy876.1075 |
| COMMON NAME | Bone and/or bone marrow aspiration/biopsy needles |
Celling Aspiration Needle PROPRIETARY NAME
IDENTIFICATION OF PREDICATE DEVICES:
The Celling Aspiration Needle was determined to be substantially equivalent to the previously cleared Argon Bone Marrow Harvest Needle, K980196, Cleared February 3, 1998. The Celling Aspiration Needle is contract manufactured to the same specifications as the predicate in the same facility, using the same methods, materials and packaging/sterilization as the predicate. The only difference is the color of the handle, needle length, and added depth markings. A secondary predicate is identified, Ranfac Bone Marrow Aspiration Needle, K131157, since the needle is currently being distributed by SpineSmith and testing was performed to ensure that it performed equivalent to the Ranfac needle for current customers.
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DEVICE DESCRIPTION:
The Celling Aspiration Needle is a single-use aspiration needle comprised of a stainless steel cannula with a molded plastic handle, and a stainless steel stylet with a molded plastic handle which mates with the cannula handle when the stylet is inserted through the cannula. While holding the mated handles, the user rotates the needle using a clockwise-counter clockwise motion while applying pressure on the bone. The needle bores into the marrow cavity. Once there the stylet is removed and aspiration is accomplished by attaching a luer syringe (not included) to the needle and applying negative pressure.
INDICATIONS:
The Celling Aspiration Needle is intended for use in aspirating bone marrow.
TECHNOLOGICAL CHARACTERISTICS:
The Celling Aspiration Needle is based on the same materials and design to the predicate device. Both devices are comprised of stainless steel tubing for the cannula and stainless steel wire for the stylet. Both devices have plastic molded handles for the cannula and stylet that mate with each other to prevent separation. Both devices have side holes to maximize aspiration and both have luer lock connections enabling the use of standard syringes.
TESTING:
The Celling Aspiration Needle has undergone non-clinical testing including mechanical, physical, component biocompatibility analysis, and performance characteristics. Testing provides reasonable assurance of safety and effectiveness for its intended use and supports a determination of substantial equivalence to the predicate device.
CONCLUSIONS:
The comparisons and testing conducted on the Celling Aspiration Needle demonstrates that the device is substantially equivalent to a marketed predicate device which is currently in commercial distribution. Additionally, it meets all of the requirements of the FDA special controls quidance (Class II Special Controls Guidance Document: Guidance for the Content of Premarket Notifications for Biopsy Devices Used in Gastroenterology and Urology).
§ 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.