The graft preparation and delivery device is intended for the delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site. In addition, it is designed to facilitate the premixing of bone graft materials with fluids such as IV fluids, blood, plasma concentrate, plasma, bone marrow or other specified blood components as deemed necessary by the clinical use requirements.

Device Description

The Graft Delivery Device with Integrated Stylet is a sterile, single-use, disposable device intended for the delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site. In addition, it is designed to facilitate the premixing of bone graft materials with fluids such as IV fluids, blood, plasma concentrate, platelet rich plasma, bone marrow or other specified blood components as deemed necessary by the clinical use requirements.

The Graft Delivery Device with Integrated Stylet consists of a syringe body, plunger with integrated stylet, tapered end cap, funnel, cap plug, and cannula. Hydration components (hydration tube or hydration adapter) are present in some configurations. Components are made of one or more of the following materials: acrylonitrile butadiene styrene (ABS), polycarbonate, polypropylene, self-lubricating silicone, and 304 Stainless Steel.

The device is packaged in a thermoformed tray with a Tyvek Iid. Each tray is then packaged in a labeled individual poly/Tyvek pouch. Five (5) pouched trays are then put into a shelf box and then a cardboard shipper box. Like the graft delivery device from K100754, the Graft Delivery Device with Integrated Stylet is sterilized using ethylene oxide.

AI/ML Overview

The provided text is for a medical device called "Graft Delivery Device with Integrated Stylet," which is classified as a piston syringe. The document describes a 510(k) premarket notification, indicating substantial equivalence to previously marketed predicate devices. This type of submission relies on non-clinical performance data rather than clinical studies in most cases.

Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" will be derived from the non-clinical performance data and the concept of "substantial equivalence."

Here's the breakdown of the information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the test articles met "pre-defined acceptance criteria," indicating a successful outcome for each test. However, the specific quantitative acceptance criteria values for each test are not provided in this summary. The "Reported Device Performance" is broadly stated as meeting these unquantified criteria.

Test Item	Acceptance Criteria (Not Quantified)	Reported Device Performance
Plunger Force	Pre-defined acceptance criteria for plunger operation requirements.	Met the pre-defined acceptance criteria.
Stylet Force	Pre-defined acceptance criteria for stylet operation requirements.	Met the pre-defined acceptance criteria.
Closed System Leak	Pre-defined acceptance criteria for leak integrity in a closed system.	Met the pre-defined acceptance criteria.
Vented System	Pre-defined acceptance criteria for vented system functionality.	Met the pre-defined acceptance criteria.
Secondary Thumb Tab Force	Pre-defined acceptance criteria for secondary thumb tab strength/force.	Met the pre-defined acceptance criteria.
Cannula Atraumatic Tip	Pre-defined acceptance criteria for atraumatic tip design and functionality.	Met the pre-defined acceptance criteria.
Dimensional Testing	Pre-defined acceptance criteria for specified dimensions.	Met the pre-defined acceptance criteria.
Cap Plug/Tapered End Cap/Syringe Finger Flange Strength	Pre-defined acceptance criteria for strength of these components.	Met the pre-defined acceptance criteria.
Plunger Thumb Pad Strength	Pre-defined acceptance criteria for plunger thumb pad strength.	Met the pre-defined acceptance criteria.
Cannula/Tapered End Cap Strength	Pre-defined acceptance criteria for strength of these connections.	Met the pre-defined acceptance criteria.
Hydration Adapter/Tapered End Cap Strength	Pre-defined acceptance criteria for strength of these connections.	Met the pre-defined acceptance criteria.
Hydration Tube/Tapered End Cap Strength	Pre-defined acceptance criteria for strength of these connections.	Met the pre-defined acceptance criteria.
Stylet Torque	Pre-defined acceptance criteria for stylet torque resistance.	Met the pre-defined acceptance criteria.
Stylet Buckling	Pre-defined acceptance criteria to prevent stylet buckling.	Met the pre-defined acceptance criteria.
Hydration Tube Strength	Pre-defined acceptance criteria for hydration tube strength.	Met the pre-defined acceptance criteria.
Sterilization	Pre-defined acceptance criteria for effective sterilization (Ethylene Oxide).	Met the pre-defined acceptance criteria.
Shelf life	Pre-defined acceptance criteria for maintaining functionality over shelf life.	Met the pre-defined acceptance criteria.
Packaging	Pre-defined acceptance criteria for packaging integrity and protection.	Met the pre-defined acceptance criteria.
Biocompatibility	Compliant with ISO 10993 Part 1 for biocontact.	Considered safe for use for its intended biocontact.

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

The document does not explicitly state the sample sizes used for each non-clinical test. This information would typically be found in the full test reports, which are not included here.

Sample Size (Test Set): Not specified in the provided summary.
Data Provenance: The tests are internal non-clinical performance tests conducted by the manufacturer (Micromedics, Inc.) to demonstrate the device's mechanical integrity and suitability for its intended use. This is inherently prospective in nature, as the tests are performed specifically for regulatory submission on the device under review. The country of origin of the data is implied to be the USA, where Micromedics, Inc. is based.

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

For non-clinical, mechanical, and biocompatibility testing, "ground truth" is established through engineering specifications, validated test methods, and international standards (like ISO 10993). This typically does not involve a panel of human experts in the same way clinical data does. The "experts" would be the engineers, quality control specialists, and external laboratory personnel who designed and executed the tests and evaluated the results against objective criteria. Their qualifications are inherent in their roles and adherence to industry standards.

4. Adjudication Method for the Test Set

Adjudication methods like "2+1" or "3+1" are relevant for clinical studies where subjective human interpretation of outputs (e.g., medical images) needs consensus. For non-clinical, objective performance tests, adjudication is not typically performed in this manner. The results are compared directly against pre-defined engineering acceptance criteria. A test either passes or fails based on objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Summary of Clinical Performance Data: None provided as a basis for substantial equivalence." This device relies on non-clinical data for its 510(k) submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. The device is a physical medical instrument (a graft delivery device), not an algorithm or AI software. Therefore, there is no "standalone performance" in the context of AI without human-in-the-loop. The non-clinical performance tests evaluate the physical device's functionality.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is comprised of:

Engineering Specifications: Designed performance parameters and tolerances for the device's physical and functional attributes.
Validated Test Methods: Established procedures to objectively measure these attributes.
International Standards: e.g., ISO 10993 for biocompatibility.
Predicate Device Performance: Implicitly, the performance of the predicate devices informed the acceptable range for the new device's non-clinical performance to establish substantial equivalence.

8. The Sample Size for the Training Set

This question is not applicable. This is a physical medical device, not an AI or machine learning model that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This question is not applicable, as there is no "training set" for a physical medical device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.

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

July 7, 2015

Micromedics Incorporated Ms. Amy L. Peterson Senior Regulatory Affairs Specialist 1270 Eagan Industrial Road, Suite 120 Saint Paul, Minnesota 55121

Re: K151543

Trade/Device Name: Graft Delivery Device with Integrated Stylet Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: Class II Product Code: FMF Dated: June 4, 2015 Received: June 8, 2015

Dear Ms. Peterson:

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

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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 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" (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 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.

Jennifer R. Stevenson -S

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) K151543

Device Name

Graft Delivery Device with Integrated Stylet

Indications for Use (Describe)

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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Date of Summary Preparation: July 3, 2015

510(k) Applicant/Submitter Micromedics, Inc. d/b/a Nordson Medical 1270 Eagan Industrial Road St. Paul, MN 55121-1385 Tel: 651-452-1977; Fax: 651-452-1787 Establishment Registration #2183425

Contact Person Amy L. Peterson, M.A. Sr. Regulatory Affairs Specialist Micromedics, Inc. d/b/a Nordson Medical 1270 Eagan Industrial Road St. Paul, MN 55121-1385 Tel: 651-405-2182; Fax: 651-452-1787

General Information
Trade Name	Graft Delivery Device withIntegrated Stylet	Common Name	Graft Delivery Device
ClassificationInformation	Syringe, Pistonper 21 CFR 880.5860 (Class II)	Product Code	FMF
		Panel	General Hospital
PredicateDevices	Micromedics Inc's Graft Delivery System, K100754, cleared June 9, 2010Biomet Biologics' CDO™ and Graft Preparation System, K072330, clearedDecember 6, 2007

Device Description

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Intended Use / Indications

The graft preparation and delivery device is intended for the delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site. In addition, it is designed to facilitate the premixing of bone graft materials with fluids such as IV fluids, blood, plasma concentrate, platelet rich plasma, bone marrow or other specified blood components as deemed necessary by the clinical use requirements.

Substantial Equivalence Comparison

The Graft Delivery Device with Integrated Stylet is substantially equivalent to the predicate devices in the following characteristics:

Operational mode
Basic Scientific Technology .
. Intended Use
General physical characteristics .

Summary of Non-Clinical Performance Data

The Graft Delivery Device with Integrated Stylet was evaluated through design verification and biocompatibility testing. Biocompatibility testing performed in accordance with ISO 10993 -Biological evaluation of medical devices, Part 1 – Evaluation and tests (2009) show the device is considered safe for use for its intended biocontact. Non-clinical testing included the tests listed below and showed the test articles met the pre-defined acceptance criteria, therefore demonstrating the mechanical integrity and suitability of the device for its intended use and over the labeled shelf life.

Testing was conducted for the following:

Plunger Force ●
Stylet Force ●
Closed System Leak ●
Vented System
Secondary Thumb Tab Force
Cannula Atraumatic Tip ●
Dimensional Testing ●
Cap Plug/Tapered End Cap/Syringe Finger Flange Strength
. Plunger Thumb Pad Strength
Cannula/Tapered End Cap Strength ●
. Hydration Adapter/Tapered End Cap Strength
Hydration Tube/Tapered End Cap Strength ●
Stylet Torque ●
. Stylet Buckling
Hydration Tube Strength ●
Sterilization ●
Shelf life ●
Packaging .
Summary of Clinical Performance Data

None provided as a basis for substantial equivalence.

Substantial Equivalence Conclusion

As evidenced by the successful completion of non-clinical performance testing, the Graft Delivery Device with Integrated Stylet does not raise new questions of safety or effectiveness when compared to the predicate devices and is, therefore, substantially equivalent.

Regulation Number and Section

§ 880.5860 Piston syringe.

(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).