(32 days)
No
The summary describes a manually operated surgical instrument with no mention of AI or ML capabilities.
No
The device is a manually operated surgical instrument used for aspirating bone marrow or blood and placing guidewires. It assists in procedures but does not inherently treat or alleviate a disease or condition itself.
No
Explanation: The device is described as a manually operated surgical instrument for aspirating bone marrow or blood and for placing guidewires, not for diagnosing a condition or disease. Its function is interventional/procedural.
No
The device description explicitly states it is a "manually operated surgical instrument," indicating it is a physical 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 aspirating bone marrow or autologous blood and placing guidewires for surgical procedures. It's about obtaining samples and facilitating surgical actions within the body, not analyzing samples outside the body to diagnose a condition.
- Device Description: The description clearly states it's a "manually operated surgical instrument" used to assist with aspiration and placing guidewires during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting substances, or providing diagnostic information based on the aspirated material. The focus is on the collection and placement aspects for surgical purposes.
IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device's function is entirely in vivo (within the body) and procedural.
N/A
Intended Use / Indications for 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.
Product codes
KNW, LXH
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.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Stryker Imbibe Needle (K140414)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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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 Orthobiologics |
| 77 Great Valley Parkway | |
| Malvern, PA 19355 | |
| Contact Person | Lynn Lundy, MBA, RAC |
| Senior Regulatory Affairs Specialist | |
| Phone: 610-407-5256 | |
| Fax: 484-328-8803 | |
| Email: 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 §876.1075 |
| Orthopedic 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 Needle | |
| characteristics, and principles of operation as its predicate. The only | |
| difference between the new and the predicate device is the design of the | |
| package. 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.