A-TAP (previously called Arthrotap)

K231900 · Elcam Medical Acal · FMF · Jul 25, 2023 · General Hospital

Device Facts

• Record ID: K231900
• Device Name: A-TAP (previously called Arthrotap)
• Applicant: Elcam Medical Acal
• Product Code: FMF · General Hospital
• Decision Date: Jul 25, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5860
• Device Class: Class 2

Indications for Use

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

Device Story

A-TAP is a single-use, disposable fluid switching device used by healthcare professionals for fluid aspiration or injection. It consists of a clear plastic barrel, a sliding rod, and three Luer lock connections (two female, one male) designed to connect to two syringes and a needle. Operation involves manually pressing the sliding rod horizontally to open and close fluid paths via internal sliding seals. The device is a pass-through component, lacks volume calibration or graduated markings, and is lubricated with polydimethylsiloxane. It is sterilized via Gamma irradiation. The device facilitates fluid management in clinical settings by allowing controlled switching between connected syringes and a needle.

Clinical Evidence

Bench testing only. No clinical data. Testing included biocompatibility (ISO 10993 series), mechanical performance (ISO 7886-1, ISO 80369-7, ISO 8536-10), sterility validation (ISO 11137), and package integrity (ASTM F1980, ASTM D4169, ASTM F2096, ASTM F88).

Technological Characteristics

Materials: Tritan (barrel), Polycarbonate (rod), Polydimethylsiloxane (lubricant). Design: 3-port Luer lock fluid switch with sliding seal mechanism. Sterilization: Gamma irradiation. Standards: ISO 7886-1, ISO 80369-7, ISO 8536-10, ISO 10993, ISO 11137, ASTM F1980, ASTM D4169, ASTM F2096, ASTM F88.

Indications for Use

Indicated for healthcare professionals for general purpose fluid aspiration/injection.

Regulatory Classification

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.

Predicate Devices

• Arthrotap (K201816)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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) | |
|----------------------------------------------------------------------------|---------------------------------------------------------------------------|
| <div> <span>☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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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: [phone] E-mail: [e-mail]

## Official Correspondent:

Shoshana (Shosh) Friedman Senior Regulatory Affairs Consultant Phone: [phone] [e-mail]

## 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 Device<br>А-ТАРТМ<br>K231900 | Predicate Device<br>Arthrotap<br>K201816 | Comparison Description<br>and Analysis |
|---------------------|-----------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The A-TAP is intended for<br>use by healthcare<br>professionals for general<br>purpose fluid<br>aspiration/injection. | The Arthrotap is intended<br>for use by healthcare<br>professionals for general<br>purpose fluid<br>aspiration/injection. | Substantially equivalent. |
| Barrel (body) | Clear Tritan | Clear Tritan | Same chemical family.<br>Biocompatibility testing was<br>performed for this material<br>change to demonstrate<br>substantial equivalence (see<br>section 9 below). |
| Rod | Polycarbonate with white<br>colorant | Polycarbonate with white<br>colorant | Same chemical family.<br>Biocompatibility testing was<br>performed for this material<br>change to demonstrate<br>substantial equivalence (see<br>section 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 Device<br>A-TAPTM<br>K231900 | Predicate Device<br>Arthrotap<br>K201816 | Comparison Description<br>and Analysis |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Luer Configuration | Luer Lock | Luer Lock | Substantially equivalent. |
| Lubrication | Polydimethylsiloxane<br>(silicone) | Polydimethylsiloxane<br>(silicone) | Same chemical family.<br>Biocompatibility and<br>performance testing were<br>performed for this material<br>change to demonstrate<br>substantial equivalence (see<br>section 9 below)). |
| Sterilization Method | Irradiation (Gamma) | Irradiation (e-beam) | Similar. Both irradiation<br>sterilization methods are<br>Established Category A1. |
| Packaging | Blister (as cleared under<br>K190489) | Pouch | Sterilization, shelf-life and<br>packaging integrity testing<br>were performed for this<br>change to demonstrate<br>substantial equivalence (see<br>section 9 below). |
| External Connections | 3 Luer connectors<br>Intended to connect to two<br>syringes and a single needle | 3 Luer connectors<br>Intended to connect to two<br>syringes and a single needle | Substantially equivalent |
| Operation /Actuation<br>Method | Pressing the sliding rod<br>horizontally to open and close<br>fluid paths by means of<br>moving sliding seals within<br>the device. | Pressing the sliding rod<br>horizontally to open and close<br>fluid paths by means of<br>moving sliding seals within<br>the device. | Substantially equivalent |
| Calibration | The A-TAP is a pass-through<br>device, is not calibrated for<br>volume, and does not have<br>graduated markings. | The Arthrotap is a pass-<br>through device, is not<br>calibrated for volume, and<br>does not have graduated<br>markings. | 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 Tests<br>Topic | 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<br>(Bench) | ISO 7886-1:2017, Sterile hypodermic syringes for single use - Part 1:<br>Syringes for manual |
| | ISO 80369-7:2021, Small-bore connectors for liquids and gases in<br>healthcare applications — Part 7: Connectors for intravascular or<br>hypodermic applications |
| | ISO 8536-10:2015, Infusion equipment for medical use — Part 10:<br>Accessories for fluid lines for single use with pressure infusion<br>equipment |
| | ANSI/AAMI/ISO 11737-1:2018, Sterilization of Health Care<br>Products - Microbiological Methods - Part 1: Determination of a<br>Population of Microorganisms on Products |
| | ANSI/AAMI/ISO 11737-2:2019, Sterilization of Medical Devices—<br>Microbiological Methods—Part 2: Tests of Sterility Performed in the<br>Definition, Validation and Maintenance of a Sterilization Process |
| Sterilization and<br>Shelf Life | ANSI/AAMI/ISO TIR13004:2013 (R2016)/ ISO 13004:2022,<br>Sterilization of Health Care Products - Radiation - Substantiation of<br>Selected Sterilization Dose: Method VDmax SD |
| | ANSI/AAMI/ISO 11137-1:2006/(R)2015 [Including: Amendment 1<br>(2013) and Amendment 2 (2019)], Sterilization of Health Care<br>Products - Radiation - Part 1: Requirements for Development,<br>Validation, and Routine Control of a Sterilization Process for<br>Medical Devices |
| | USP <85> Bacterial Endotoxin |
| Package Integrity | ASTM F 1980-16, Standard Guide for Accelerated Aging of Sterile<br>Barrier Systems for Medical Devices |
| | ASTM D 4169-16, Standard Practice for Performance Testing of<br>Shipping Containers and Systems |
| | ASTM F2096-11 (Reapproved 2019), Standard Test Method for<br>Detecting Gross Leaks in Packaging by Internal Pressurization<br>(Bubble Test) |
| | ASTM F88/F88M-21, Standard Test Method for Seal Strength of<br>Flexible 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).