The Concert Medical Hands-Free Syringe (HFS) is an infiltration pump used to infuse fluids (such as regional anesthetics) into the body. The HFS consists of a sterile, single-use plastic syringe (20 mL capacity) fitted with a custom plunger, a reusable motor housing, and a reusable foot pedal. The user fills the syringe with the fluid of choice, then locks the filled syringe into the motor housing, where the specially designed syringe plunger rack mates with the custom plunger housing gear. The male luer fitting of a sterile, single-use needle set (not supplied by Concert Medical) is attached to the standard female luer fitting on the HFS syringe. The foot pedal connector is plugged into the receptacle on the motor housing, then the foot pedal is placed in a convenient location on the floor. The motor housing contains non-replaceable AAA batteries, which power a small DC motor which in turn controls the movement of the syringe plunger. The foot pedal consists of a color-coded rubber bar; when the user applies light foot pressure to the appropriate half of the foot pedal (green = infuse; yellow = aspirate), the motor activates the plunger movement mechanism to move the plunger forward (infuse) or backward (aspirate). The motor control is designed to deliver fluid at a maximum flow rate of 0.5 mL/sec. The motor is designed with an overpressure safety feature, which causes the plunger movement to stop if the pressure in the syringe exceeds 15 psi regardless of whether the "infuse" portion of the foot pedal is depressed. The motor housing has three LED indicator lights for real-time display of the syringe plunger action: a green light illuminates when the syringe is infusing, a yellow light illuminates when the syringe is aspirating, and a red light illuminates if the plunger movement has stopped because the 15 psi pressure limit has been reached. The foot pedal control provides the user with two-handed control of the needle placement without the need for a second person to manipulate the syringe plunger for infusion or aspiration.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the Concert Medical Hands-Free Syringe (HFS) based on the provided document:

This document does not describe an AI/ML device, therefore many of the requested fields (multi-reader multi-case study, standalone performance, training set details, ground truth for training) are not applicable. The device is a physical medical device (an infiltration pump).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table with specific acceptance criteria values alongside their corresponding reported performance values for each test. Instead, it offers a general statement that the device "met pre-determined acceptance criteria."

However, we can infer some criteria and performance from the "Device Description" and "Non-Clinical Performance Testing" sections:

Acceptance Criteria (Inferred)	Reported Device Performance
Foot pedal control functionality: Ability to infuse/aspirate upon foot pedal depression.	"When the user applies light foot pressure to the appropriate half of the foot pedal (green = infuse; yellow = aspirate), the motor activates the plunger movement mechanism to move the plunger forward (infuse) or backward (aspirate)."
Overpressure cutoff functionality: Stop plunger movement if pressure exceeds a threshold.	"The motor is designed with an overpressure safety feature, which causes the plunger movement to stop if the pressure in the syringe exceeds 15 psi regardless of whether the 'infuse' portion of the foot pedal is depressed." This is compared to the predicate device's maximum infusion pressure of 14.8 psi and a referenced device having a 15 psi limit.
Maximum flow rate: Delivery of fluid at a specified maximum rate.	"The motor control is designed to deliver fluid at a maximum flow rate of 0.5 mL/sec."
Syringe plunger control functionality: Motor controls plunger movement accurately.	The device description outlines this functionality, and the "Non-Clinical Performance Testing" lists "foot pedal / syringe plunger control functionality" as tested. The conclusion states all criteria were met.
Limited reuse functionality: For motor control unit and foot pedal.	Implied to have passed, as "limited reuse functionality testing of the motor control unit and foot pedal" was conducted, and the conclusion states all criteria were met.
Electrical safety/EMC: Compliance with relevant standards.	Implied to have passed, as "electrical safety/EMC testing" was conducted, and the conclusion states all criteria were met.

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

The document does not specify the sample size for the non-clinical performance testing. It also does not mention data provenance in terms of country of origin or whether the study was retrospective or prospective, as these are typically considerations for clinical data, which is not described here.

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

This question is not applicable as the "test set" here refers to physical performance testing of a medical device, not a diagnostic or AI/ML algorithm requiring expert-established ground truth from data. No experts were involved in establishing "ground truth" for pressure, flow rate, or electrical safety tests.

4. Adjudication Method for the Test Set

This question is not applicable for the same reasons as point 3. Adjudication methods are typically used for reconciling disagreements among human readers or for establishing consensus ground truth in studies involving human interpretation, not for physical device performance tests.

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. This type of study is relevant for AI/ML diagnostic tools that impact human reader performance. The Concert Medical HFS is a physical medical device (an infiltration pump), not a diagnostic algorithm.

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

No, a standalone study was not done. This concept applies to AI/ML algorithms, not physical devices. The device's performance is inherently linked to its physical operation, which is what was tested.

7. The Type of Ground Truth Used

For the non-clinical performance testing, the "ground truth" would be established by:

Measurement against objective physical standards: For flow rate, pressure, and electrical safety, the "ground truth" is derived from direct measurements using calibrated instruments and comparison to predefined engineering specifications and regulatory limits (e.g., 15 psi pressure limit, 0.5 mL/sec flow rate).
Functional verification: For foot pedal and syringe plunger control, the "ground truth" is simply whether the device functions as designed (e.g., foot pedal depression leads to infusion/aspiration).

8. The Sample Size for the Training Set

This question is not applicable. The Concert Medical Hands-Free Syringe is a physical device, not an AI/ML system. Therefore, there is no "training set" in the context of machine learning.

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

This question is not applicable for the same reason as point 8.

Summary

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

September 1, 2016

Concert Medical, LLC % Ms. Pamela Papineau, RAC Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue Ayer, Massachusetts 01432

Re: K153599

Trade/Device Name: Concert Medical Hands-Free Syringe (HFS) Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion pump Regulatory Class: Class II Product Code: FRN Dated: August 8, 2016 Received: August 9, 2016

Dear Ms. Papineau:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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" (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,

Christopher J. Ronk -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) K153599

Device Name

Concert Medical Hands-Free Syringe (HFS)

Indications for Use (Describe)

The Concert Medical Hands-Free Syringe (HFS) is indicated for general fluid irrigation/infiltration.

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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Appendix C – 510(k) Summary (revised)

General Information

Date Prepared:	August 26, 2016
Owner's Name:	Concert Medical, LLC
Address:	77 Accord Park DriveNorwell, MA 02061
Owner Contact Person:	Timothy S. Powers, V.P. Operations/Regulatory
Telephone Number:	781-261-7407
Regulatory Contact Person:	Pamela Papineau, RAC
Telephone Number:	978-772-3552
Subject Device Name:	Concert Medical Hands-Free Syringe (HFS)
Trade Name:	Concert Medical Hands-Free Syringe (HFS)
Common/Usual Name:	Infusion Pump
Product Code:	FRN
Classification Name:	Infusion Pump21 CFR 880.5725; Class II
Predicate Device:	Psi-Tec Syringe Infusion Pump and Accessories
Trade Name:	Psi-Tec Syringe Infusion Pump and Accessories
Common/Usual Name:	Infusion Pump
Product Code:	FRN
Classification Name:	Infusion Pump21 CFR 880.5725; Class II
Premarket Notification:	K980738; Byron Medical Psi-Tec Syringe Infusion Pump andAccessoriesSE date June 16, 1998
Primary Reference Device:	KleinTouch Pump
Trade Name:	KleinTouch Pump
Common/Usual Name:	Infusion Pump
Product Code:	FRN
Classification Name:	Infusion Pump21 CFR 880.5725; Class II
Premarket Notification:	K123822; HK Surgical KleinTouch PumpSE date September 27, 2013

Indications for Use

The Concert Medical Hands-Free Syringe is indicated for general fluid irrigation/infiltration.

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Device Description

Substantial Equivalence

The Concert Medical HFS is substantially equivalent to the Byron Medical Psi-Tec Syringe Infusion Pump and Accessories, which was cleared in K980738. The Psi-Tec Syringe Infusion Pump consists of a pneumatic-driven syringe pump used to irrigate or infuse fluids contained in a reservoir consisting of a sterile, disposable 10 mL piston syringe with a standard luer connector that is attached to a sterile, disposable tubing set for delivery of the fluid contained in the syringe. As for the Concert Medical Hands-Free Syringe, infusion/aspiration using the Psi-Tec Syringe Infusion Pump is controlled via a foot pedal. Flow rates for the Psi-Tec Syringe Infusion Pump range from 0 - 600 mL/min. The maximum infusion pressure of the Concert Medical Hands-Free Syringe (15 psi) is equivalent to that of the Psi-Tec Syringe Infusion Pump (14.8 psi). The Macosta Medical B-Smart Nerve Block Injection Pressure Manometer (K031128), which is used in conjunction with a standard infiltration anesthesia needle set to limit infusion pressure to a maximum of 15 psi, is cited as a reference device for the maximum 15 psi infusion pressure of the Concert Medical HFS.

The HK Surgical KleinTouch Pump, which was cleared in K123822, is cited as a reference device for the Concert Medical Hands-Free Syringe. The KleinTouch Pump is indicated for use as an infiltration pump used to cause a flow of fluid from an IV bag into a patient in a manner controlled manually by a health care professional. The KleinTouch Pump consists of a powered (battery or AC), reusable peristaltic roller pump that achieves fluid movement via force exerted

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by three rollers on the plastic tubing connecting the fluid reservoir (IV bag) to the infusion needle. The KleinTouch Pump is used with the sterile, single-use KT20 KleinTouch Tubing. The user activates the KleinTouch Pump via a foot pedal. The KleinTouch Pump can be used with 12g - 20g needles; infusion flow rates of 50 - 1000 mL/min are available depending on the selected needle gauge.

This 510(k) includes a second reference device, the Macosta Medical B-Smart Nerve Block Injection Pressure Manometer (K031128); the B-Smart device is used in conjunction with a standard infiltration anesthesia needle set to limit infusion pressure to a maximum of 15 psi.

Non-Clinical Performance Testing

Performance data demonstrated that the Concert Medical HFS has met pre-determined acceptance criteria and is substantially equivalent to the predicate device. The risks associated with the new device were found acceptable when evaluated in accordance with ISO 14971:2007. Performance testing included in this 510(k) consists of foot pedal / syringe plunger control functionality, overpressure cutoff functionality, maximum flow rate testing, flow rate measurement, limited reuse functionality testing of the motor control unit and foot pedal, and electrical safety/EMC testing. This submission also includes an Infusion Pump Safety Case and the results of a Human Factors study.

Conclusion

The Concert Medical Hands-Free Syringe (HFS) meets all pre-determined acceptance testing criteria performed to confirm substantial equivalence to the predicate device.

Regulation Number and Section

§ 880.5725 Infusion pump.

(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).