The A-TAP device is a fluid switching medical device consisting of a clear plastic barrel body, a sliding rod, two 6% female Luer lock connections, and one 6% male Luer lock connection. The internal surface of the device barrel body is lubricated with polydimethylsiloxane (silicone). The A-TAP is a single-use only, disposable, non-pyrogenic and sterilized by Gamma irradiation.

AI/ML Overview

The provided text is a 510(k) summary for the A-TAP device, which is a fluid switching medical device. The submission is a Special 510(k) due to modifications made to the previously cleared Arthrotap device (K201816) by Elcam Medical.

The acceptance criteria and study proving the device meets these criteria concern the physical and biological characteristics of the device, not an AI/ML-driven diagnostic or prognostic tool. Therefore, the questions related to AI/ML performance metrics, sample sizes for training/test sets for AI, expert adjudication of ground truth, and MRMC studies are not applicable in this context.

This document details the tests performed to demonstrate that the modified A-TAP device is substantially equivalent to its predicate.

Here's a breakdown of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance tests conducted to demonstrate substantial equivalence, implying that passing these tests served as the acceptance criteria. The "Reported Device Performance" is stated by the successful completion of all listed tests.

Acceptance Criteria (Measured by Passing Standard/Method)	Reported Device Performance
Biocompatibility:	All tests successfully passed
Cytotoxicity (ISO 10993-5)
Irritation (ISO 10993-10)
Sensitization (ISO 10993-10)
Acute Systemic Toxicity (ISO 10993-11)
Material-Mediated Pyrogenicity (ISO 10993-11/USP<151>)
Hemolysis (ISO 10993-4)
Non-Clinical (Bench) Testing:	All tests successfully passed
ISO 7886-1:2017 (Sterile hypodermic syringes for single use)
ISO 80369-7:2021 (Small-bore connectors for liquids and gases)
ISO 8536-10:2015 (Infusion equipment for medical use)
ANSI/AAMI/ISO 11737-1:2018 (Sterilization of Health Care Products - Microbiological Methods - Part 1)
ANSI/AAMI/ISO 11737-2:2019 (Sterilization of Medical Devices - Microbiological Methods - Part 2)
Sterilization and Shelf-Life:	All tests successfully passed
ANSI/AAMI/ISO TIR13004:2013 (R2016)/ ISO 13004:2022 (Radiation - Substantiation of Selected Sterilization Dose)
ANSI/AAMI/ISO 11137-1:2006/(R)2015 [Including: Amendment 1 (2013) and Amendment 2 (2019)] (Sterilization of Health Care Products - Radiation - Part 1)
USP <85> Bacterial Endotoxin
Package Integrity:	All tests successfully passed
ASTM F 1980-16 (Accelerated Aging of Sterile Barrier Systems)
ASTM D 4169-16 (Performance Testing of Shipping Containers and Systems)
ASTM F2096-11 (Reapproved 2019) (Detecting Gross Leaks in Packaging)
ASTM F88/F88M-21 (Seal Strength of Flexible Barrier Materials)
USP <788 > Particulate Matter in Injections

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

The document concerns a physical medical device and its components, not a data-driven AI/ML model for which test sets from patients are required. Therefore, typical "sample sizes" in the context of clinical data for AI are not applicable. The tests performed are laboratory-based, often involving a certain number of device units or material samples as specified by the respective ISO/ASTM standards. The data provenance is laboratory testing conducted by or for Elcam Medical. The document does not specify country of origin for the testing itself, nor if it was retrospective or prospective in the clinical sense, as it refers to engineering verification and validation testing.

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

Not applicable. Ground truth for a physical device's performance (e.g., material compatibility, structural integrity, sterility) is established by adherence to recognized international and national standards (ISO, ASTM, USP) and the results of the specified tests, rather than expert consensus on clinical data.

4. Adjudication Method for the Test Set:

Not applicable for a physical device. Performance is determined by meeting the pass/fail criteria defined within the referenced standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

Not applicable. This type of study is relevant for diagnostic imaging AI, not for a fluid switching device.

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

Not applicable for a physical medical device without AI components.

7. The Type of Ground Truth Used:

The ground truth used for proving the device meets acceptance criteria is based on standardized test methods and their defined performance criteria. For example, biocompatibility is evaluated against specific biological responses according to ISO standards, and mechanical integrity is evaluated against criteria set by ISO or ASTM standards. This is not derived from expert consensus, pathology, or outcomes data in the typical clinical sense, but from engineering and material science principles.

8. The Sample Size for the Training Set:

Not applicable. This device does not involve an AI/ML algorithm that requires a training set.

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

Not applicable, as there is no training set for an AI/ML algorithm.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

July 25, 2023

Elcam Medical ACAL % Shoshana Friedman Senior Regulatory Consultant ProMedoss Inc. 3521 Hatwynn Rd Charlotte, North Carolina 28269

Re: K231900

Trade/Device Name: A-TAP Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: June 28, 2023 Received: June 28, 2023

Dear Shoshana Friedman:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Sincerely,

Alan Stth

CAPT Alan M. Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K231900

Device Name A-TAP

Indications for Use (Describe)

The A-TAP is intended for use by healthcare professionals for general purpose fluid aspiration.

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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Image /page/3/Picture/0 description: The image shows the logo for Elcam Medical. The logo consists of a stylized "E" symbol in orange and gray, followed by the text "Elcam" in dark gray, with "MEDICAL" below it in a smaller font. Below the text is the tagline "Where everything connects" in a smaller, lighter font.

SPECIAL 510(K) SUMMARY A-TAPTM 510(k) Number K231900

1. SUBMITTER

Applicant's Name:

Elcam Medical ACAL Kibbutz BarAm Israel 1386000

Company Primary Contact:

Yaniv Menachem Regulatory Affairs Manager Phone: + 972-77-2568662 Mobile: +972-528695824 E-mail: yaniv.m@elcam.co.il

Official Correspondent:

Shoshana (Shosh) Friedman Senior Regulatory Affairs Consultant Phone: (704) 430-8695 s.friedman@promedoss.com

2. DATE PREPARED

July 21, 2023

3. DEVICE

Device Trade Name:	A-TAP
Classification Name:	Syringe, Piston
Product Code:	FMF
Regulation No:	21 CFR §880.5860
Regulatory Class:	Class II

4. PREDICATE DEVICE

Predicate Trade Name: Arthrotap Predicate 510(k) No.:

5. DEVICE DESCRIPTION

The A-TAP device is a fluid switching medical device consisting of a clear plastic barrel body, a sliding rod, two 6% female Luer lock connections, and one 6% male Luer lock connection.

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Image /page/4/Picture/0 description: The image shows the logo for Elcam Medical. The logo features a stylized "E" in orange and gray, followed by the words "Elcam MEDICAL" in a bold, sans-serif font. Below the company name is the tagline "Where everything connects" in a smaller, lighter font.

The internal surface of the device barrel body is lubricated with polydimethylsiloxane (silicone).

The A-TAP is a single-use only, disposable, non-pyrogenic and sterilized by Gamma irradiation.

6. REASON FOR SUBMISSION

The original Arthrotap device (now named A-TAP) was designed by Accuro Technologies and was cleared on October 16, 2020, under K201816.

Elcam Medical acquired the Arthrotap device from Accuro Technologies and Accuro Technologies transferred the ownership of the 510(k) number K201816 for the Arthrotap to Elcam Medical. As a result of Elcam Medical becoming the legal manufacturer of the device, several modifications were implemented, as presented in this Special 510(k) submission: materials change, irradiation method & packaging material and minor geometric design modifications.

7. INDICATIONS FOR USE

The A-TAP is intended for use by healthcare professionals for general purpose fluid aspiration/injection.

8. SUBSTANTIAL EQUIVALENCE

Equivalency of device and its predicate is demonstrated in Table 1 below through a direct comparison of the A-TAP and the predicate device (Arthrotap).

Characteristics	Subject DeviceА-ТАРТМK231900	Predicate DeviceArthrotapK201816	Comparison Descriptionand Analysis
Indications for Use	The A-TAP is intended foruse by healthcareprofessionals for generalpurpose fluidaspiration/injection.	The Arthrotap is intendedfor use by healthcareprofessionals for generalpurpose fluidaspiration/injection.	Substantially equivalent.
Barrel (body)	Clear Tritan	Clear Tritan	Same chemical family.Biocompatibility testing wasperformed for this materialchange to demonstratesubstantial equivalence (seesection 9 below).
Rod	Polycarbonate with whitecolorant	Polycarbonate with whitecolorant	Same chemical family.Biocompatibility testing wasperformed for this materialchange to demonstratesubstantial equivalence (seesection 9 below).
Sealing Mechanism	O-rings	O-rings	Similar sealing mechanism.

Table 1: Comparison Table

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Image /page/5/Picture/0 description: The image shows the logo for Elcam Medical. The logo consists of a stylized "E" shape in orange and gray, followed by the words "Elcam" in bold, dark gray letters. Below "Elcam" is the word "MEDICAL" in smaller, dark gray letters. Underneath the company name is the tagline "Where everything connects" in a smaller, lighter gray font.

Characteristics	Subject DeviceA-TAPTMK231900	Predicate DeviceArthrotapK201816	Comparison Descriptionand Analysis
Luer Configuration	Luer Lock	Luer Lock	Substantially equivalent.
Lubrication	Polydimethylsiloxane(silicone)	Polydimethylsiloxane(silicone)	Same chemical family.Biocompatibility andperformance testing wereperformed for this materialchange to demonstratesubstantial equivalence (seesection 9 below)).
Sterilization Method	Irradiation (Gamma)	Irradiation (e-beam)	Similar. Both irradiationsterilization methods areEstablished Category A1.
Packaging	Blister (as cleared underK190489)	Pouch	Sterilization, shelf-life andpackaging integrity testingwere performed for thischange to demonstratesubstantial equivalence (seesection 9 below).
External Connections	3 Luer connectorsIntended to connect to twosyringes and a single needle	3 Luer connectorsIntended to connect to twosyringes and a single needle	Substantially equivalent
Operation /ActuationMethod	Pressing the sliding rodhorizontally to open and closefluid paths by means ofmoving sliding seals withinthe device.	Pressing the sliding rodhorizontally to open and closefluid paths by means ofmoving sliding seals withinthe device.	Substantially equivalent
Calibration	The A-TAP is a pass-throughdevice, is not calibrated forvolume, and does not havegraduated markings.	The Arthrotap is a pass-through device, is notcalibrated for volume, anddoes not have graduatedmarkings.	Substantially equivalent

The above comparison table demonstrates that Elcam's modified A-TAP is substantial equivalent to the predicate device (Arthrotap).

The raw materials change (all within the same chemical family), the change in irradiation method, and consequently, packaging change as well as the minor geometric design modifications do not alter neither the basic design nor the operation mechanism of the device, as supported by the results of the verification and validation tests.

It was, therefore, our conclusion that the A-TAP with the modifications requested in this submission is substantially equivalent to the market-cleared Arthrotap (cleared under K201816), without raising any new safety and/or effectiveness concerns.

1 Per FDA guidance "Submission and Review of Sterility Information in Premarket Notification for Devices Labeled as Sterile" issued on January 21, 2016

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Image /page/6/Picture/0 description: The image shows the logo for Elcam Medical. The logo consists of a stylized letter "E" made up of gray and orange lines, followed by the text "Elcam" in a dark gray sans-serif font. Below "Elcam" is the word "MEDICAL" in a smaller, dark gray sans-serif font. Underneath the word "MEDICAL" is the tagline "Where everything connects" in a smaller, lighter gray font.

9. PERFORMANCE DATA

Elcam's A-TAP successfully passed all the tests listed in Table 2 below.

Table 2: Performance TestsTopic	Standard/Method
Biocompatibility	Cytotoxicity (ISO 10993-5)
	Irritation (ISO 10993-10)
	Sensitization (ISO 10993-10)
	Acute Systemic Toxicity (ISO 10993-11)
	Material-Mediated Pyrogenicity (ISO 10993-11/USP<151>)
	Hemolysis (ISO 10993-4)
Non-Clinical(Bench)	ISO 7886-1:2017, Sterile hypodermic syringes for single use - Part 1:Syringes for manual
	ISO 80369-7:2021, Small-bore connectors for liquids and gases inhealthcare applications — Part 7: Connectors for intravascular orhypodermic applications
	ISO 8536-10:2015, Infusion equipment for medical use — Part 10:Accessories for fluid lines for single use with pressure infusionequipment
	ANSI/AAMI/ISO 11737-1:2018, Sterilization of Health CareProducts - Microbiological Methods - Part 1: Determination of aPopulation of Microorganisms on Products
	ANSI/AAMI/ISO 11737-2:2019, Sterilization of Medical Devices—Microbiological Methods—Part 2: Tests of Sterility Performed in theDefinition, Validation and Maintenance of a Sterilization Process
Sterilization andShelf Life	ANSI/AAMI/ISO TIR13004:2013 (R2016)/ ISO 13004:2022,Sterilization of Health Care Products - Radiation - Substantiation ofSelected Sterilization Dose: Method VDmax SD
	ANSI/AAMI/ISO 11137-1:2006/(R)2015 [Including: Amendment 1(2013) and Amendment 2 (2019)], Sterilization of Health CareProducts - Radiation - Part 1: Requirements for Development,Validation, and Routine Control of a Sterilization Process forMedical Devices
	USP <85> Bacterial Endotoxin
Package Integrity	ASTM F 1980-16, Standard Guide for Accelerated Aging of SterileBarrier Systems for Medical Devices
	ASTM D 4169-16, Standard Practice for Performance Testing ofShipping Containers and Systems
	ASTM F2096-11 (Reapproved 2019), Standard Test Method forDetecting Gross Leaks in Packaging by Internal Pressurization(Bubble Test)
	ASTM F88/F88M-21, Standard Test Method for Seal Strength ofFlexible Barrier Materials
	USP <788 > Particulate Matter in Injections

Table 2: Performance Tests

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Image /page/7/Picture/0 description: The image shows the logo for Elcam Medical. The logo features a stylized "E" made of gray and orange lines, followed by the words "Elcam MEDICAL" in bold, gray letters. Below the company name is the tagline "Where everything connects" in a smaller, lighter font.

The evaluation of Elcam's A-TAP by the tests detailed above demonstrated that the A-TAP device is as safe and as effective as the predicate device (Arthrotap).

10. CONCLUSION

The modifications discussed in this submission do not introduce new risks, do not affect the functionality of the device, and do not alter any of the labeling claims.

Therefore, it was concluded that Elcam's modified A-TAP is substantially equivalent to the Arthrotap previously cleared (K201816).

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).