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.

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. kwires) for orthopedic surgery. These guidewires may be used to place other hardware utilized in orthopedic procedures including pedicle screws.

AI/ML Overview

This document describes a 510(k) premarket notification for the Stryker Imbibe Needle, a manually operated surgical instrument. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific performance metrics against pre-defined acceptance criteria. Therefore, several requested fields related to a detailed performance study are not applicable or cannot be extracted from the provided text.

Here is an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present explicit, quantifiable acceptance criteria with corresponding performance statistics. Instead, it relies on demonstrating "substantial equivalence" to a predicate device. The comparison points are primarily design features and intended uses, implying that if the new device shares these characteristics and performs similarly, it meets the "acceptance criteria" for substantial equivalence.

Feature / Criterion	Imbibe Needle (New Device)	Imbibe Needle (Predicate Device, K050795)
Indications for Use	Aspirating bone marrow or autologous blood + Placement of guidewires	Aspirating bone marrow or autologous blood
Product Code	KNW, LXH	KNW
Product Design	Handle with cannula, removable stylet	Handle with cannula, removable stylet
Stylet Tip Design	Trocar, Beveled	Trocar
Fenestrated Offering	Yes	Yes
Male Luer Connection For Syringe Attachment	Yes	Yes
Sterilization and SAL	Gamma irradiation, 10-6	Gamma irradiation, 10-6
Biocompatibility	Externally communicating device with tissue/blood/dentin contact for a duration of less than 24 hours	Externally communicating device with tissue/blood/dentin contact for a duration of less than 24 hours

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not explicitly stated as a numerical sample size for a "test set" in the context of a performance study. The document mentions "Preclinical bench data supplied including mechanical and cadaveric testing." However, the exact number of devices tested, samples used in mechanical tests, or cadavers utilized is not provided.
Data Provenance: The testing appears to be internal preclinical bench and cadaveric testing conducted by Orthovita, Inc. (now Stryker). The country of origin is not specified but implicitly within the US given the FDA submission. It is retrospective in the sense that the data was collected prior to the submission, but the tests were presumably prospective in their execution.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

Not Applicable (N/A): This type of information is pertinent to studies involving human interpretation (e.g., imaging studies, diagnostic tools). The described tests are mechanical and cadaveric, which do not typically involve experts establishing a "ground truth" through consensus or interpretation. The performance is assessed against engineering specifications or physical outcomes.

4. Adjudication Method for the Test Set:

N/A: As explained above, this concept is not relevant to the type of preclinical bench and cadaveric testing described.

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:

N/A: This submission is for a surgical instrument, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and AI-related effectiveness are not applicable.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

N/A: This submission is for a physical surgical instrument. The concept of "standalone algorithm performance" is not applicable.

7. The Type of Ground Truth Used:

For the mechanical testing, the "ground truth" would be established by engineering specifications, material properties, and expected mechanical responses (e.g., force, torque, fatigue limits).
For the cadaveric testing, the "ground truth" would be the observed physical outcome and ability to perform the intended surgical actions (e.g., successful aspiration, accurate guidewire placement) in a simulated anatomical environment. This is typically assessed against established surgical techniques and anatomical knowledge.

8. The Sample Size for the Training Set:

N/A: This concept is relevant for machine learning or AI models. This submission is for a physical medical device and therefore does not have a "training set" in that context. The development process would involve iterative design, prototyping, and testing, but not a formally defined "training set" for an algorithm.

9. How the Ground Truth for the Training Set was Established:

N/A: As above, this concept is not applicable to the development and testing of a physical surgical instrument.

Summary

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APR 0 1 2014

510(k) SUMMARY Stryker Imbibe Needle

February 18th, 2014

K140414 510(k) Number (if known):

1. Contact Person

John Urtz Senior Regulatory Affairs Specialist (e-mail) john.urtz@stryker.com

Orthovita, Inc. 77 Great Valley Parkway Malvern, PA 19355 (t) 610-407-7450 - (f) 484-323-8803

2. Device Name and Classification

Product Name: Classification Name:

Common or Usual Name: Regulation Number:

Reviewing Panel:

Device Class: Product Code: Imbibe Needle Instrument, Biopsy Orthopedic Manual Surgical Instrument Gastroenterology-urology biopsy instrument 876.1075 888.4540 Gastroenterology/Urology Surgical, Orthopedic, and Restorative Devices Class II KNW LXH

3. Predicate Device(s)

Orthovita Inc.'s Imbibe Needle (K050795)

4. Device Description

5. 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.

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6. Performance Data

ﺎﻧﻴﺔ ﺍﻟﺘﻲ

Preclinical bench data supplied including mechanical and cadaveric testing demonstrates that the Imbibe Needle is substantially equivalent to the predicate device and any differences do not raise new questions of safety and effectiveness. Further, this testing supports the Imbibe Needle's ability to assist in the placement of guidewires.

7. Substantial Equivalence

	Imbibe NeedlePredicate DeviceK050795	Imbibe NeedleNew DeviceTBD
INDICATIONS FORUSE	The Imbibe Needle is for use inaspirating Bone Marrow orautologous blood by use of asyringe. The bone marrow orautologous blood may be combinedwith bone graft or bone void filler.	The Imbibe Needle is for use inaspirating bone marrow or autologousblood by use of a syringe. The bonemarrow or autologous blood may becombined with bone graft or bone voidfiller.The Imbibe Needle is also for use inthe placement of guidewires (e.g. k-wires) during orthopedic surgery.
PRODUCT CODE	KNW	KNW, LXH
PRODUCT DESIGN	Handle with cannula, removable	Handle with cannula, removable stylet
STYLET TIP DESIGN	Trocar	Trocar, Beveled
FENESTRATEDOFFERING	Y es	Yes
MALE LUERCONNECTION FORSYRINGEATTACHMENT	Yes	Yes
STERILIZATION ANDSAL	Gamma irradiation, 10-6	Gamma irradiation, 10-6
BIOCOMPATIBILITY	Externally communicating devicewith tissue/blood/dentin contact fora duration of less than 24 hours	Externally communicating device withtissue/blood/dentin contact for aduration of less than 24 hours

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features the department's name encircling a symbol. The symbol is a stylized representation of an eagle or bird-like figure, with three curved lines forming the body and wings.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Dacument Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 1, 2014

Orthovita Incorporated Mr. John Urtz Senior Regulatory Affairs Specialist 77 Great Valley Parkway Malvern, Pennsylvania 19355

Re: K140414

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: February 18, 2014 Received: February 18, 2014

Dear Mr. Urtz:

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 cither 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 r that FDA has made a determination that your device complies with other requirements of the Act that I Dr Hoo master and regulations administered by other Federal agencies. You must Or any I cachar statines and regiraments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical Cl N F art 6077, abouting (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. John Urtz

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,

Felipe Aquel

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known):_K140414

Device Name: Imbibe Needle

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.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR Over-The Counter Use x (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation

Felipe Aguel

Date: 2014.04.01 16:08:02 -04'00'

Regulation Number and Section

§ 888.4540 Orthopedic manual surgical instrument.

(a)
Identification. An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.