The SmartJet Grafting Liquid Applicator is intended for the application of fluids, as deemed necessary by the surgeon's determination of the clinical use requirements, to facilitate the preparation of soft tissue autograft or allograft material prior to the application of the graft material to a repair site.

Device Description

The Harvest SmartJet Grafting Liquid Applicator is provided sterile in a sealed pouch and is intended for a single use. The device consists of the following components:
Two commercially available disposable medical piston syringes.
Applicator Tip (spray or dual cannula)
Handle Frame, and
Plunger Clip

AI/ML Overview

This 510(k) summary for the Harvest SmartJet Grafting Liquid Applicator indicates that the device has been found substantially equivalent to a predicate device (Harvest SmartJet Bone Grafting Liquid Applicator, cleared under 510(k)011032) based on technological characteristics and design. It states that the proposed device has the same technological characteristics and is identical in design and configuration to the predicate device, and the materials of manufacture have been demonstrated to be suitable for the intended use.

This implies that the acceptance criteria for this 510(k) submission were primarily based on demonstrating substantial equivalence to the predicate device, rather than explicit performance metrics from an independent study in the current filing. The FDA's letter confirms substantial equivalence without requiring a new clinical study.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied by 510(k) Process)	Reported Device Performance
Substantial Equivalence to Predicate Device	Device is "identical in design and configuration" and has "the same technological characteristics" as the predicate device (Harvest SmartJet Bone Grafting Liquid Applicator, K011032). Materials are suitable for intended use.

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

No explicit test set or clinical study data is provided in this 510(k) summary for the Harvest SmartJet Grafting Liquid Applicator to demonstrate performance against specific criteria. The submission relies on the established substantial equivalence to the predicate device.

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

Not applicable, as no new test set requiring expert ground truth establishment for performance evaluation against specific metrics is described in this 510(k) summary.

4. Adjudication Method for the Test Set:

Not applicable, as no new test set requiring adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study is mentioned for this 510(k) submission.

6. Standalone (Algorithm Only) Performance Study:

Not applicable, as this device is a manual surgical instrument, not an algorithm.

7. Type of Ground Truth Used:

Not applicable, as no new study requiring ground truth is described. The "truth" in this context is the FDA's acceptance of substantial equivalence to a previously cleared device.

8. Sample Size for the Training Set:

Not applicable, as this device is a manual surgical instrument and does not involve a "training set" in the context of an algorithm.

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

Not applicable, as this device is a manual surgical instrument and does not involve a "training set" or ground truth establishment in this manner.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" that proves the device meets the acceptance criteria is the 510(k) review process itself, which concluded that the Harvest SmartJet Grafting Liquid Applicator is substantially equivalent to its predicate device, the Harvest SmartJet Bone Grafting Liquid Applicator (K011032). This determination was based on:

Comparison of Technological Characteristics/Performance Data: The submission explicitly states, "The proposed device has the same technological characteristics and is identical in design and configuration compared with the predicate device. The materials of manufacture have been demonstrated to be suitable for the intended use specified."
Predicate Device Equivalence: The predicate device had already undergone FDA clearance, meaning its safety and effectiveness for its intended use were established. By demonstrating that the new device is essentially the same in terms of design, materials, and intended purpose (with an expanded indications for use that was also deemed acceptable), the need for new, extensive performance studies was circumvented.

The FDA's decision to clear the device "based upon the information you supplied, we have determined the device is substantially equivalent" confirms that this comparison was sufficient to meet their regulatory requirements for acceptance. No new independent performance studies or clinical trials specific to this 510(k) for this device are described in the provided text.

Summary

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APR - 5 2002

K020252 1/2

510(k) Summary for the Harvest Technologies SmartJet Liquid Grafting Applicator

Applicant's Name and Address:

Phone Number: Telefax Number: Contact Person:

Date Summary Prepared:

Device Trade Name:

Common name:

Classification name:

Substantial Equivalence:

Predicate Device:

Device Description:

Intended Use:

Harvest Tlechnologies Corp. 40 Grissom Road, Suite 100 Plymouth, MA 02360

508-732-7500 508-732-0400 John D. Bonasera Director of Regulatory and Quality Affairs

March 11, 2002

Harvest SmartJet Grafting Liquid Applicator

Applicator, Liquid

Manual Surgical Instrument (21 CFR 878.4800)

The device has been cleared by the FDA via the 510(k) Notification process. The purpose of this submission was to describe an expanded indications for use statement.

The SmartJet Grafting Liquid Applicator is substantially equivalent to the Harvest SmartJet Bone Grafting Liquid Applicator cleared by FDA in 510(k)011032

The Hanvest SmartJet Grafting Liquid Applicator is provided sterile in a sealed pouch and is intended for a single use. The device consists of the following components:

Two commercially available disposable medical piston syringes. Applicator Tip (spray or dual cannula) Handle Frame, and Plunger Clip

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Technological Characteristics/ Performance Data

The proposed device has the same technological characteristics and is identical in design and configuration compared with the predicate device. The materials of manufacture have been demonstrated to be suitable for the intended use specified.

....

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Image /page/2/Picture/0 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" arranged around the circumference. Inside the circle is a stylized image of a human figure, represented by three curved lines that form the profile of a face and neck.

DEPARTMENT OF HEALTH & HUMAN SERVICES

od and Drug Administration 200 Corporate Boulevard Rockville MD 20850

Harvest Technologies, Corp. Mr. John D. Bonasera Director of Regulatory Affairs 40 Grissom Road, Suite 100 Plymouth, Massachusetts 02360

APR = 5 2002

Re: K020252

ke. Kozo292 Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: January 20, 2002 Received: January 24, 2002

Dear Mr. Bonasera:

We have reviewed your Section 510(k) premarket notification of intent to market the we have forlowed four booms. bave determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate (101 the marculonions 10. 28, 1976, the enactment date of the Medical Device commerce pror to ria) =e that have been reclassified in accordance with the provisions Afthe Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a or mo Feation 1 001, 27 way, therefore, market the device, market the device, subject to promatics approval approval apprisions 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations (1 writ), it may be basjon be found in the Code of Federal Regulations, Title 21, Parts arroomig your 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 r loase on that FDA has made a determination that your device complies with other not mean that I Driving or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not I vartal to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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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Page 2 -- Mr. John Bonasera

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your s ro(is) premiers of predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 11 You debro possible as a rart 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, (Misbranding by reference to premarket notification( (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 6382041 or (301) 4436597 or at its Internet address HYPERLINK http://www.fda.gov/cdrh/dsma/dsmamain.html http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

uriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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cc: HFZ-401 DMC . HFZ-404 510(k) Staff
HFZ-410 DGRND
D.O. HFZ-404 510(k) Staff D.O. . . . f/t:410:YPak:mep:3/12/02

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INDICATIONS FOR USE STATEMEN

Page 1 of 1

510(k) Number: K020252

SmartJet Gratting Liquid Applicator Device Name:

The SmartJet (rafting Liquid Applicator is intended for the application of fluids, Indications for Use: as deemed necessary by the surgeon's determination of the clinical use requirements, to facilitate the preparation of soft tissue autograft or allograft material prior to the application of the graft material to a repair site.

(Please do not write below this line-continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Use (Per 21 CFR 801.109)

Over-The-Counter

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K020252

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).