(27 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a fluid aspiration device, with no mention of AI or ML.
No
The device is described as being for "general purpose fluid aspiration," which is a diagnostic or procedural function rather than a therapeutic one aiming to treat or cure a disease or condition.
No
The device is for general purpose fluid aspiration and fluid switching, which are functional purposes rather than diagnostic ones. No part of the description indicates it is used to identify or analyze a condition or disease.
No
The device description clearly outlines physical components (barrel body, sliding rod, Luer lock connections) and mentions material properties and sterilization, indicating it is a hardware device.
Based on the provided information, the A-TAP device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for general purpose fluid aspiration." This describes a physical action of removing fluid from the body, not analyzing a sample of fluid in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a device for fluid switching and connection, consistent with a tool for fluid handling, not a device designed to perform diagnostic tests on a sample.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze the aspirated fluid, detect biomarkers, or provide any diagnostic information.
- Performance Studies: The performance studies focus on the physical and biological safety and functionality of the device itself (biocompatibility, bench tests based on ISO standards for medical devices, sterilization, shelf life, package integrity), not on the accuracy or performance of a diagnostic test.
IVD devices are specifically designed to examine specimens (like blood, urine, tissue) in vitro to provide information for diagnosis, monitoring, or screening. The A-TAP's function is purely for the physical act of aspirating fluid.
N/A
Intended Use / Indications for Use
The A-TAP is intended for use by healthcare professionals for general purpose fluid aspiration/injection.
Product codes
FMF
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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Elcam's A-TAP successfully passed all the tests listed in Table 2. The evaluation included Biocompatibility tests (Cytotoxicity, Irritation, Sensitization, Acute Systemic Toxicity, Material-Mediated Pyrogenicity, Hemolysis), Non-Clinical (Bench) tests (ISO 7886-1:2017, ISO 80369-7:2021, ISO 8536-10:2015, ANSI/AAMI/ISO 11737-1:2018, ANSI/AAMI/ISO 11737-2:2019), Sterilization and Shelf Life tests (ANSI/AAMI/ISO TIR13004:2013 (R2016)/ ISO 13004:2022, ANSI/AAMI/ISO 11137-1:2006/(R)2015, USP Bacterial Endotoxin), and Package Integrity tests (ASTM F 1980-16, ASTM D 4169-16, ASTM F2096-11 (Reapproved 2019), ASTM F88/F88M-21, USP Particulate Matter in Injections). The evaluation demonstrated that the A-TAP device is as safe and as effective as the predicate device (Arthrotap).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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
2
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.
4
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
А-ТАРТМ
K231900 | Predicate Device
Arthrotap
K201816 | Comparison Description
and Analysis |
|---------------------|-----------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The A-TAP is intended for
use by healthcare
professionals for general
purpose fluid
aspiration/injection. | The Arthrotap is intended
for use by healthcare
professionals for general
purpose fluid
aspiration/injection. | Substantially equivalent. |
| Barrel (body) | Clear Tritan | Clear Tritan | Same chemical family.
Biocompatibility testing was
performed for this material
change to demonstrate
substantial equivalence (see
section 9 below). |
| Rod | Polycarbonate with white
colorant | Polycarbonate with white
colorant | Same chemical family.
Biocompatibility testing was
performed for this material
change to demonstrate
substantial equivalence (see
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
A-TAPTM
K231900 | Predicate Device
Arthrotap
K201816 | Comparison Description
and Analysis |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Luer Configuration | Luer Lock | Luer Lock | Substantially equivalent. |
| Lubrication | Polydimethylsiloxane
(silicone) | Polydimethylsiloxane
(silicone) | Same chemical family.
Biocompatibility and
performance testing were
performed for this material
change to demonstrate
substantial equivalence (see
section 9 below)). |
| Sterilization Method | Irradiation (Gamma) | Irradiation (e-beam) | Similar. Both irradiation
sterilization methods are
Established Category A1. |
| Packaging | Blister (as cleared under
K190489) | Pouch | Sterilization, shelf-life and
packaging integrity testing
were performed for this
change to demonstrate
substantial equivalence (see
section 9 below). |
| External Connections | 3 Luer connectors
Intended to connect to two
syringes and a single needle | 3 Luer connectors
Intended to connect to two
syringes and a single needle | Substantially equivalent |
| Operation /Actuation
Method | Pressing the sliding rod
horizontally to open and close
fluid paths by means of
moving sliding seals within
the device. | Pressing the sliding rod
horizontally to open and close
fluid paths by means of
moving sliding seals within
the device. | Substantially equivalent |
| Calibration | The A-TAP is a pass-through
device, is not calibrated for
volume, and does not have
graduated markings. | The Arthrotap is a pass-
through device, is not
calibrated for volume, and
does not have graduated
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
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) | |
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 in | |
healthcare applications — Part 7: Connectors for intravascular or | |
hypodermic applications | |
ISO 8536-10:2015, Infusion equipment for medical use — Part 10: | |
Accessories for fluid lines for single use with pressure infusion | |
equipment | |
ANSI/AAMI/ISO 11737-1:2018, Sterilization of Health Care | |
Products - Microbiological Methods - Part 1: Determination of a | |
Population of Microorganisms on Products | |
ANSI/AAMI/ISO 11737-2:2019, Sterilization of Medical Devices— | |
Microbiological Methods—Part 2: Tests of Sterility Performed in the | |
Definition, Validation and Maintenance of a Sterilization Process | |
Sterilization and | |
Shelf Life | ANSI/AAMI/ISO TIR13004:2013 (R2016)/ ISO 13004:2022, |
Sterilization of Health Care Products - Radiation - Substantiation of | |
Selected Sterilization Dose: Method VDmax SD | |
ANSI/AAMI/ISO 11137-1:2006/(R)2015 [Including: Amendment 1 | |
(2013) and Amendment 2 (2019)], Sterilization of Health Care | |
Products - Radiation - Part 1: Requirements for Development, | |
Validation, and Routine Control of a Sterilization Process for | |
Medical Devices | |
USP Bacterial Endotoxin | |
Package Integrity | ASTM F 1980-16, Standard Guide for Accelerated Aging of Sterile |
Barrier Systems for Medical Devices | |
ASTM D 4169-16, Standard Practice for Performance Testing of | |
Shipping Containers and Systems | |
ASTM F2096-11 (Reapproved 2019), Standard Test Method for | |
Detecting Gross Leaks in Packaging by Internal Pressurization | |
(Bubble Test) | |
ASTM F88/F88M-21, Standard Test Method for Seal Strength of | |
Flexible Barrier Materials | |
USP 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).