The ARTHROTAP 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 ARTHROTAP device barrel body is lubricated with polydimethylsiloxane (silicone). The ARTHROTAP is single-use only, non-pyrogenic, and sterilized by electron beam irradiation.

AI/ML Overview

The medical device in question, ARTHROTAP, is a fluid switching medical device intended for general purpose fluid aspiration/injection. The document describes its substantial equivalence to a predicate device, the ANUTRA Feedback Aspiration Syringe (K143757), based on a comparison of technological characteristics and performance testing.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by meeting relevant ISO and ASTM standards. The reported device performance indicates that ARTHROTAP successfully passed these tests.

Acceptance Criteria Category	Specific Tests/Standards Met	Reported Device Performance
General Syringe Performance	ISO 7886-1:2017 (Sterile hypodermic syringes for single use) sections covering: General, Limits for Acidity or Alkalinity, Limits for Extractable Metals, Lubricant, Barrel, Piston/plunger assembly (Annex B), Nozzle, Freedom from air and liquid leakage (Annex B & D), Force to operate piston (Annex E), Fit of plunger in barrel, Packaging, Labeling.	ARTHROTAP passed all applicable sections, demonstrating its general safety and functionality as a single-use fluid aspiration/injection device. Sections for graduated capacity and scale were not applicable as ARTHROTAP does not have these features. Dead space was also not applicable. The device successfully demonstrated the ability to hold a seal.
Small-Bore Connectors	ISO 80369-7:2016 (Small-bore connectors) and ISO 80369-20:2015 (Common Test Methods) sections covering: Dimensional Requirements, Liquid leakage from fitting assembly under pressure (Annex C), Sub-atmospheric Air leakage into fitting assembly during aspiration (Annex D), Stress Cracking (Annex E), Resistance to separation from axial load (Annex F), Resistance to separation from unscrewing (Annex G), Resistance to overriding (Annex H).	ARTHROTAP successfully met these standards, ensuring secure and leak-free connections to other medical devices like syringes and needles, addressing potential concerns about its multiple Luer connectors compared to the predicate.
Sterile Barrier Packaging	ASTM F1980-16 Environmental Conditioning, ASTM D4169-16 Distribution Simulation, Label Inspection for overall adhesion and legibility, ASTM F2096-11 Standard Test Method for Detecting Gross Leaks in Porous Medical Packaging by Internal Pressurization (Bubble Leak), ASTM F88 / F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials.	Packaging tests demonstrated that the ARTHROTAP maintains its sterility and integrity throughout environmental conditioning and distribution, and its labels are durable and legible. The device achieves a level of safety equivalent to the predicate.
Biocompatibility	ISO 10993-1:2009 (Biocompatibility) sections covering: Cytotoxicity by Elution Test, Maximization Test for Delayed Hypersensitivity, Intracutaneous Reactivity, Acute Systemic Toxicity, Evaluation of Hemocompatibility: Interaction with Blood. Also, ISO 10993-12 & USP <151> (Pyrogenicity), USP 40 <85> Bacterial Endotoxin (LAL), USP <788> Particulate Matter In Injections.	ARTHROTAP was tested and found to meet all specified biological requirements as outlined in ISO 10993-1 and FDA guidance. This included all tests conducted on the predicate plus additional tests for Pyrogenicity and LAL, demonstrating safety substantially equivalent or better than the predicate. The device is safe for patient contact.
Sterilization	Bioburden (ANSI/AAMI/ISO 11737-1:2006), Bioburden Validation (ANSI/AAMI/ISO 11737-1:2006), VD Maximum Dose (ANSI/AAMI/ISO TIR13004:2013), Sterility Verification (ANSI/AAMI/ISO 11737-2:2009/(R) 2014), Dose Mapping (ISO 11137-1:2006), Device Sterilization (ANSI/AAMI/ISO 11737-2:2009/(R) 2014).	Sterilization testing demonstrated the safety of ARTHROTAP concerning sterility, using established and recognized methods. While not explicitly listed for the predicate, these tests confirm the ARTHROTAP's sterility. The use of e-beam irradiation, a "Category A" method, is considered equivalent to gamma irradiation used for the predicate.

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes used for each individual test. It states that "Performance testing of ARTHROTAP was conducted and evaluated in accordance with [various ISO and ASTM standards]".

The data provenance is from non-clinical testing conducted by the manufacturer, Accuro Technologies Inc., to demonstrate substantial equivalence to a legally marketed predicate device. This is typically laboratory-based testing, not human patient data. The country of origin of the data is not explicitly stated, but the manufacturer is based in Canada.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable to this type of device and study. The "ground truth" for the performance tests outlined (e.g., leakage, material strength, biocompatibility) is determined by meeting the quantitative and qualitative requirements of the respective international standards (ISO, ASTM). This is not typically established by human expert consensus or qualifications in the same way clinical imaging or diagnostic device studies do.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are usually relevant for expert consensus on clinical findings, particularly in studies involving interpretation of medical images or symptoms. The described tests for ARTHROTAP are objective performance and safety evaluations against established technical standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no mention of an MRMC comparative effectiveness study, AI assistance, or human readers. This device is a fluid switching component, not a diagnostic imaging or AI-powered device.

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

There is no mention of any algorithm-only or AI-related performance testing. The ARTHROTAP is a physical medical device, not a software algorithm.

7. The type of ground truth used

The "ground truth" for this device's evaluation is based on established objective technical standards (ISO and ASTM) and biocompatibility guidelines. For example:

Performance: Meeting specified limits for leakage, operating force, dimensional requirements, etc., as defined by the international standards.
Biocompatibility: Absence of cytotoxicity, sensitization, irritation, systemic toxicity, hemolysis, particulate matter, and detection of pyrogens/endotoxins, as per ISO 10993 and USP standards.
Sterilization: Demonstration of sterility assurance level (SAL) according to ISO standards.

8. The sample size for the training set

This information is not applicable. The ARTHROTAP is a physical medical device, not a machine learning model, so there is no concept of a "training set."

9. How the ground truth for the training set was established

This information is not applicable, as there is no training set for this device.

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 16, 2020

Accuro Technologies Inc. Michael Dolphin Chief Technology Officer 201-2067 Cadboro Bay Rd Victoria, BC V8R 5G4 Canada

Re: K201816

Trade/Device Name: Arthrotap Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: October 2, 2020 Received: October 2, 2020

Dear Michael Dolphin:

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,

For CAPT Alan 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) K201816

Device Name ARTHROTAP

Indications for Use (Describe)

The ARTHROTAP 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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510(k) SUMMARY

K201816

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:

l. SUBMITTER Accuro Technologies, Inc. 201-2067 Cadboro Bay Rd. Victoria, BC CANADA V8R 5G4 Phone: 250-940-0015
Contact Person: Michael Dolphin, CTO Phone: 604-970-2714 Email: mdolphin@accurotechnology.com Date Prepared: October 8, 2020
II. DEVICE

Name of Device:	ARTHROTAP
Regulation Name:	Syringe, Piston
Regulation number:	21 CFR §880.5860
Regulatory Class:	Class II
Product Code:	FMF

III. PREDICATE DEVICE

Predicate Manufacturer:	Anutra Medical, Inc.
Predicate Trade Name:	Anutra Feedback Aspiration Syringe
Predicate 510(k):	K143757

No reference devices were used in this submission.

DEVICE DESCRIPTION IV.

The ARTHROTAP 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

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

The ARTHROTAP is single-use only, non-pyrogenic, and sterilized by electron beam irradiation.

INTENDED USE V.

The ARTHROTAP is intended for use by healthcare professionals for general purpose fluid aspiration/injection.

PREDICATE DEVICE COMPARISON – TECHNOLOGICAL CHARACTERISTICS VI.

Equivalency of technical characteristics is demonstrated through a direct comparison of the ARTHROTAP and the predicate device listed in the table below.

TechnicalCharacteristic	Subject Device:ARTHROTAP	Predicate Device:ANUTRA FeedbackAspiration Syringe(K143757)	Differences and impact on Safetyand Efficacy
Indications forUse	Intended for use byhealthcareprofessionals forgeneral purpose fluidaspiration/injection.	Intended for use byhealthcareprofessionals forgeneral purpose fluidaspiration/injection.	No difference.
Barrel (body)	Yes (clear TritanCopolyester)	Yes (clearPolypropylenecopolymer)	No new safety concerns asARTHROTAP passed allbiocompatibility tests.
Rod	Yes (sliding; whitepolycarbonate)	Yes (plunging; clearPolypropylenecopolymer)	No new safety concerns asARTHROTAP passed allbiocompatibility tests.
SealingMechanism	O-rings (silicone)	Plunger (silicone)	No difference.
LuerConfiguration	Luer Lock	Luer Lock	No difference.
Lubrication	Polydimethylsiloxane(silicone)	Polydimethylsiloxane(silicone)	No difference.
SterilizationMethod	Irradiation (e-beam)	Irradiation (Gamma)	Both e-beam and gamma areestablished "Category A" sterilizationmethods which use irradiation. Thereare no new concerns for safety orefficacy.

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Externalconnections	Has 3 Luerconnectors.Intended to connectto two syringes and asingle needle	Has 1 Luerconnector.Intended to connectto a single needle	Additional connections (to syringes)does not pose new concerns as theARTHROTAP is intended to beconnected to syringes, which havethe same safety and efficacyconcerns as the ANUTRA syringe.Both devices are intended to beconnected to a needle, which has nonew concerns.
Operation /Actuationmethod	Pressing the slidingrod horizontally toopen and close fluidpaths by means ofmoving sliding sealswithin the device.	Pressing or pullingthe sliding rodvertically to move thesliding seal within thedevice to compressor expand hollowspace inside cylinder.	The method of operation for bothdevices involves moving slidingseals within the device by means ofpressing (or pulling) on a sliding rod.There are no new safety or efficacyconcerns, as the method of sealingis the same (sliding seals), and themethod of operation is very similar.
Calibration	The ARTHROTAP isa pass-throughdevice, is notcalibrated forvolume, and doesnot have graduatedmarkings.	ls calibrated, and hasgraduated markings	There are no new safety or efficacyconcerns with the ARTHROTAP asthe device is a pass-through deviceand does not require calibration orgraduated markings. (Forprocedures where graduatedmarkings are required, users canattach a calibrated syringe to theARTHROTAP).

The predicate device is a piston syringe intended for general purpose fluid aspiration and injection. The ARTHROTAP is a fluid switching device intended for general purpose aspiration and injection. The intended use for the ARTHROTAP is the same as its predicate device, the ANUTRA Feedback Aspiration Syringe (K143757).

Barrel (body)

Both the ARTHROTAP and ANUTRA Feedback Aspiration Syringe have clear bodies made from plastic. The ARTHROTAP does not hold or measure quantities of fluid, but allows fluid to be passed through it; whereas the ANUTRA Feedback Aspiration Syringe can hold a 5 mL nominal fluid volume, indicated by graduation marks printed on the outside of the barrel.

Luer Configuration

Both the ARTHROTAP and ANUTRA Feedback Aspiration Syringe have male Luer locks intended to connect to an external needle (not provided). Additionally, the ARTHROTAP has two female Luer locks intended to connect with external syringes (not provided).

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Nominal Fluid Volume

The nominal fluid volume for one fluid pathway of the ARTHROTAP is 250 µLor 0.25 mL (it is a pass-through device and not intended to hold fluids). The ANUTRA Feedback Aspiration Syringe has a nominal fluid volume of 5 mL.

Lubrication

The internal surface of both the ARTHROTAP and ANUTRA Feedback Aspiration Syringe is lubricated with a polydimethylsiloxane (silicone).

Plunger Rod & Plunger

Both the ARTHROTAP and the ANUTRA Feedback Aspiration Syringe device have a plastic rod to operate the device. The ARTHROTAP has a sliding rod and the ANUTRA Feedback Aspiration Syringe has a plunging rod. Both devices have a rod which attach with snap-fit retention features. The ARTHROTAP and ANUTRA Feedback Aspiration Syringe rods both contain features which provide tactile feedback when the plunger is advanced or retracted.

Sterilization Method

Both the ARTHROTAP and the ANUTRA Feedback Aspiration Syringe are sterilized using irradiation. ARTHROTAP is sterilized using electron beam irradiation; the ANUTRA Feedback Aspiration Syringe is sterilized using gamma irradiation.

External connections

Both the ARTHROTAP and the ANUTRA Feedback Aspiration Syringe have external Luer connections. The ARTHROTAP has two female Luers and one male Luer; the ANUTRA Feedback Aspiration Syringe has one male Luer.

Operation / Actuation method

Both the ARTHROTAP and the ANUTRA Feedback Aspiration Syringe are operated by means of a sliding rod with internal sealing mechanism. The ARTHROTAP's rod is operated horizontally by means of pressing either side; the ANUTRA Feedback Aspiration Syringe's rod is operated vertically by means of pushing and pulling.

Calibration

The ARTHROTAP does not have a calibration feature as it is a pass-through device; the ANUTRA Feedback Aspiration Syringe has graduated marks for calibration.

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Materials

The ARTHROTAP is constructed of the following materials:

Barrel (body): Tritan Copolyester .
Sliding Rod, End Cap, End Covers: Polycarbonate .
O-rings: Dow Corning QP1-50 Silicone ●
Lubricant: Polydimethylsiloxane (silicone) .

The ARTHROTAP and ANUTRA Feedback Aspiration Syringe have both been tested and found to meet the biological requirements outlined in ISO 10993-1 (biocompatibility).

Predicate Device Comparison - Performance Characteristics

The performance data supplied with this submission demonstrates that the ARTHROTAP meets the specified requirements and is substantially equivalent to the predicate device.

The predicate device (ANUTRA Feedback Aspiration Syringe) provided an overview of testing completed in the 510(k) Summary (K143757). The following tests were performed to demonstrate safety and effectiveness and are substantially equivalent to the tests performed on the ANUTRA Feedback Aspiration Syringe.

Tests performed on Subject Device:

ISO 7886-1:2017 (Sterile hypodermic syringes for single use)

Section 5 (General)
. Section 6.2 (Limits for Acidity or Alkalinity)
. Section 6.3 (Limits for Extractable Metals)
. Section 7 (Lubricant)
Section 8 (Tolerance on graduated capacity) - N/A, no graduated capacity on ARTHROTAP
. Section 9 (Graduated scale)- N/A, no graduated scale on ARTHROTAP
. Section 10 (Barrel)
Section 11 (Piston/plunger assembly); Annex B
Section 12 (Nozzle)
Section 13.1 (Dead Space) - N/A
. Section 13.2 (Freedom from air and liquid leakage); Annex B & Annex D
Section 13.3 (Force to operate piston); Annex E
Section 13.4 Fit of plunger in barrel
Section 14 (Packaging)
. Section 15 (Labeling)

ISO 80369-7:2016 (Small-bore connectors), using test methods provided in [section] of ISO 80369-20:2015 (Common Test Methods)

Section 5 (Dimensional Requirements)
. Section 6.1 (Liquid leakage from fitting assembly under pressure), [Annex C]

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Section 6.2 (Sub-atmospheric Air leakage into fitting assembly during aspiration), [Annex D]
. Section 6.3 (Stress Cracking), [Annex E]
. Section 6.4 (Resistance to separation from axial load), [Annex F]
Section 6.5 (Resistance to separation from unscrewing), [Annex G]
. Section 6.6 (Resistance to overriding), [Annex H]

Sterile Barrier Packaging Testing

. ASTM F1980-16 Environmental Conditioning
ASTM D4169-16 Distribution Simulation ●
Label Inspection for overall adhesion and legibility (Pass/Fail) ●
ASTM F2096-11 Standard Test Method for Detecting Gross Leaks in Porous Medical . Packaging by Internal Pressurization (Bubble Leak).
. ASTM F88 / F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials.

ISO 10993-1:2009 (Biocompatibility)

Section 6.2.2.2 Cytotoxicity by Elution Test (Cytotoxicity) ●
Section 6.2.2.3 Maximization Test for Delayed Hypersensivity (Sensitization)
. Section 6.2.2.4 Intracutaneous Reactivity (Irritation or Intracutaneous Reactivity)
. Section 6.2.2.5 Acute Systemic Toxicity (Systemic Toxicity (Acute))
. Section 6.2.2.9 Evaluation of Hemocompatibility: Interaction with Blood (Hemocompatibility/Hemolysis)
ISO 10993-12 & USP <151>(Pyrogenicity)
. USP 40 <85> Bacterial Endotoxin (LAL)
USP <788> Particulate Matter In Injections

(Sterilization)

. Bioburden (ANSI/AAMI/ISO 11737-1:2006)
Bioburden Validation (ANSI/AAMI/ISO 11737-1:2006) ●
VD Maximum Dose (ANSI/AAMI/ISO TIR13004:2013)
. Sterility Verification (ANSI/AAMI/ISO 11737-2:2009/(R) 2014)
Dose Mapping (ISO 11137-1:2006) .
. Device Sterilization (ANSI/AAMI/ISO 11737-2:2009/(R) 2014)

Discussion of Non-Clinical Testing

Performance testing of ARTHROTAP was conducted and evaluated in accordance with ISO 7886-1 "Sterile hypodermic syringes for single use - Part 1: Syringes for manual use", and according to ISO 80369-7 "Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications", using test methods provided in ISO 80369-20 "Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common Test Methods". Demonstration of meeting these standards was

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considered important to demonstrate safety and efficacy of ARTHRTOAP and for demonstrating substantial equivalence to the predicate device, particularly in operation of the plunger rod and the ability of the device to hold a seal.

Package testing was conducted in accordance with ASTM F1980-16, ASTM D4169-16, ASTM F2096-11, ASTM F88 / F88M-15, meeting a level of safety demonstrated by the predicate device.

Biological specifications were determined in adherence to guidelines for the contact classification of: External communicating device, Blood path indirect, limited duration (< 24 hr). Biocompatibility testing was conducted in accordance with the FDA guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part1: Evaluation and testing within a risk management process", June 16, 2016, and ISO 10993-1 "Biological evaluation of medical devices - Part1: Evaluation and testing within a risk management process". The battery of testing included all tests conducted on the predicate, plus additional testing for Pyrogenicity and LAL, demonstrating safety of the device substantially equivalent or better than the predicate device.

Sterilization testing, including testing for Bioburden, Maximum Dose and Dose mapping, was conducted in accordance with ISO 11737-1, ISO 11737-2, ISO 11137-1, and ISO TIR13004. Sterilization testing is not listed for the predicate device, however, these tests demonstrated safety of ARTHROTAP for purposes of sterility.

Conclusion

Test results demonstrated that the ARTHROTAP is as safe, as effective, and performs as well as or better than the legally marketed predicate device (ANUTRA Feedback Aspiration Syringe). Based on comparisons of the device's intended use, technology and performance characteristics, the ARTHROTAP is substantially equivalent to the indicated predicate device. Any differences between the ARTHROTAP and the ANUTRA Feedback Aspiration Syringe have no significant influence on safety or effectiveness.

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).