(32 days)
The Imbibe Needle is for use in aspirating bone marrow or autologous blood by use of a syringe. The bone marrow or autologous blood may be combined with bone graft or bone void filler.
The Imbibe Needle is also for use in the placement of guidewires (e.g. k-wires) during orthopedic surgery.
The Imbibe Needle is a manually operated surgical instrument to assist with the aspiration of autologous blood or bone marrow and/or placing guidewires (e.g. k-wires) for orthopedic surgery. These guidewires may be used to place other hardware utilized in orthopedic procedures including pedicle screws.
This document describes the regulatory submission for the "Imbibe Needle" and its substantial equivalence to a predicate device. It primarily focuses on the device's design and intended use, rather than a clinical study evaluating its performance against specific acceptance criteria in the context of an AI-powered device.
Therefore, many of the requested categories related to acceptance criteria, device performance, a study design (like sample size, ground truth, expert involvement, and MRMC studies) are not applicable or cannot be extracted from the provided text for this specific device. This is a medical device clearance, not an AI/software as a medical device (SaMD) submission.
Here's an analysis based on the provided text, indicating where information is present and where it is not applicable for this type of submission:
Acceptance Criteria and Device Performance
Since this is a submission for a physical medical device (a needle) and not an AI/software device, the concept of "acceptance criteria" and "device performance" as measured by metrics like sensitivity, specificity, or accuracy in a diagnostic context (which is typical for AI devices) does not directly apply here. Instead, the "performance" relates to its physical characteristics, safety, and functionality.
The document states: "Previous testing of the predicate device (i.e. mechanical, cadaveric testing and biocompatibility) has demonstrated that Imbibe Needle is safe and effective for its intended use." This indicates that the predicate device met certain performance criteria through those types of tests. The current submission's "performance data" is the assertion that the new device is the same as the predicate and therefore inherits its safety and effectiveness profile.
| Category | Description / N/A (for this document) |
|---|---|
| 1. Acceptance Criteria and Reported Device Performance | Not directly applicable in the AI/diagnostic sense. The document states "Previous testing of the predicate device (i.e. mechanical, cadaveric testing and biocompatibility) has demonstrated that Imbibe Needle is safe and effective for its intended use." This implies that the predicate device met performance criteria for its physical function, safety, and compatibility, which the new device is asserted to match. Specific numerical acceptance criteria (e.g., in terms of force, duration, material compatibility) for these tests are not provided in this summary but would have been part of the predicate's original submission. The reported "performance" for the new device is that it is identical to the predicate and thus "safe and effective for its intended use." |
| 2. Sample size and data provenance for test set | Not applicable for this type of submission. No "test set" in the context of diagnostic performance data for an algorithm is described. The "cadaveric testing" for the predicate device would have involved a sample of cadavers, but the size is not specified in this document. |
| 3. Number of experts and qualifications for ground truth | Not applicable for this type of submission. No "ground truth" establishment by experts for diagnostic performance is described. |
| 4. Adjudication method for test set | Not applicable for this type of submission. |
| 5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study | No. This type of study is not relevant for a physical biopsy needle. |
| 6. Standalone (algorithm only) performance study | No. This is a physical device, not an algorithm. |
| 7. Type of ground truth used | Not applicable for this type of submission. For the predicate, "mechanical, cadaveric testing and biocompatibility" would have relied on objective measurements and established scientific/engineering principles for ground truth. |
| 8. Sample size for training set | Not applicable for this type of submission. There is no "training set" for an algorithm discussed. |
| 9. How training set ground truth was established | Not applicable for this type of submission. |
In summary, this document is a 510(k) summary for a physical medical device (Imbibe Needle) seeking substantial equivalence to a previously cleared predicate device. The primary "study" proving it meets criteria is the assertion that it is "the same device as the predicate" with only a packaging change, and thus inherits the safety and effectiveness demonstrated by the predicate through "mechanical, cadaveric testing and biocompatibility." The detailed aspects of an AI/SaMD performance study are not present.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Orthovita Incorporated Ms. Lynn Lundy, MBA, RAC Senior Regulatory Affairs Specialist 77 Great Valley Parkway Malvern, Pennsylvania 19355
December 18, 2015
Re: K153306
Trade/Device Name: Imbibe Needle Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: KNW, LXH Dated: November 13, 2015 Received: November 16, 2015
Dear Ms. Lundy:
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 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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Joshua C. Nipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. For 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) K153306
Device Name Imbibe Needle
Indications for Use (Describe)
The Imbibe Needle is for use in aspirating bone marrow or autologous blood by use of a syringe. The bone marrow or autologous blood may be combined with bone graft or bone void filler.
The Imbibe Needle is also for use in the placement of guidewires (e.g. k-wires) during orthopedic surgery.
| 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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8. 510(k) Summary
| 510(k) Summary: Imbibe Needle | |
|---|---|
| Submitter: | Stryker Orthobiologics77 Great Valley ParkwayMalvern, PA 19355 |
| Contact Person | Lynn Lundy, MBA, RACSenior Regulatory Affairs SpecialistPhone: 610-407-5256Fax: 484-328-8803Email: Lynn.Lundy@Stryker.com |
| Date Prepared | November 13, 2015 |
| Trade Name | Imbibe Needle |
| Common Name | Gastroenterology-urology biopsy instrument |
| Proposed Class | Class II |
| Classification Names and Numbers | Instrument, Biopsy 21 CFR §876.1075Orthopedic Manual Surgical Instrument 21 CFR §888.4540 |
| Product Code | KNW LXH |
| Predicate Devices | Stryker Imbibe Needle (K140414) |
| Device Description | The Imbibe Needle is a manually operated surgical instrument to assist with the aspiration of autologous blood or bone marrow and/or placing guidewires (e.g. k-wires) for orthopedic surgery. These guidewires may be used to place other hardware utilized in orthopedic procedures including pedicle screws. |
| Intended Use | The Imbibe Needle is for use in aspirating bone marrow or autologous blood by use of a syringe. The bone marrow or autologous blood may be combined with bone graft or bone void filler.The Imbibe Needle is also for use in the placement of guidewires (e.g. k-wires) during orthopedic surgery. |
| Summary of the Technological Characteristics | As established in this submission, the Imbibe Needle was shown to be substantially equivalent and has equivalent technological characteristics to its predicate device through comparison in areas including intended use, material composition, principles of operation and design. |
| Summary of the Performance Data | The new Imbibe Needle, subject of this Special 510(k), is the same device as the predicate. Previous testing of the predicate device (i.e. mechanical, cadaveric testing and biocompatibility) has demonstrated that Imbibe Needle is safe and effective for its intended use. |
| Conclusion | The proposed Imbibe Needle has identical indications, technological |
| 510(k) Summary: Imbibe Needlecharacteristics, and principles of operation as its predicate. The onlydifference between the new and the predicate device is the design of thepackage. A risk analysis was performed to demonstrate the Imbibe Nee |
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mbibe Needle package. TTSK andrysis was performed to demonstrate the mione Noodle
with new packaging is substantially equivalent to the predicate device. The design verifications and validations performed as a result of the risk analysis and presented herein demonstrate the proposed device does not raise new questions of safety or effectiveness. Thus, the predicate device (K140414) and proposed device are considered substantially equivalent.
§ 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.