(107 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML.
No.
The device is intended for "general purpose fluid aspiration," which is a diagnostic or procedural function, not a therapeutic one.
No
Explanation: The device is intended for "general purpose fluid aspiration," which is a procedure for removing fluid from the body, not for diagnosing a condition.
No
The device description clearly outlines physical components (plastic barrel body, sliding rod, Luer lock connections) and mentions material properties (polydimethylsiloxane lubrication). The performance studies focus on physical characteristics and sterilization, not software functionality.
Based on the provided information, the ARTHROTAP device is not an In Vitro Diagnostic (IVD).
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 outside the body to provide diagnostic information.
- Device Description: The description details a mechanical device for fluid handling (barrel, rod, Luer connections). It doesn't mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting analytes, or providing diagnostic results. The performance studies focus on the mechanical and biological safety of the device for fluid aspiration, not on the accuracy of any diagnostic measurements.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The ARTHROTAP's function is to collect fluid, not to analyze it for diagnostic purposes.
N/A
Intended Use / Indications for Use
The ARTHROTAP is intended for use by healthcare professionals for general purpose fluid aspiration.
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
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.
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)
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 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 (
§ 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). 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
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,
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
2
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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3
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
4
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.
| Technical
Characteristic | Subject Device:
ARTHROTAP | Predicate Device:
ANUTRA Feedback
Aspiration Syringe
(K143757) | Differences and impact on Safety
and Efficacy |
|-----------------------------|----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | Intended for use by
healthcare
professionals for
general purpose fluid
aspiration/injection. | Intended for use by
healthcare
professionals for
general purpose fluid
aspiration/injection. | No difference. |
| Barrel (body) | Yes (clear Tritan
Copolyester) | Yes (clear
Polypropylene
copolymer) | No new safety concerns as
ARTHROTAP passed all
biocompatibility tests. |
| Rod | Yes (sliding; white
polycarbonate) | Yes (plunging; clear
Polypropylene
copolymer) | No new safety concerns as
ARTHROTAP passed all
biocompatibility tests. |
| Sealing
Mechanism | O-rings (silicone) | Plunger (silicone) | No difference. |
| Luer
Configuration | Luer Lock | Luer Lock | No difference. |
| Lubrication | Polydimethylsiloxane
(silicone) | Polydimethylsiloxane
(silicone) | No difference. |
| Sterilization
Method | Irradiation (e-beam) | Irradiation (Gamma) | Both e-beam and gamma are
established "Category A" sterilization
methods which use irradiation. There
are no new concerns for safety or
efficacy. |
5
| External
connections | Has 3 Luer
connectors.
Intended to connect
to two syringes and a
single needle | Has 1 Luer
connector.
Intended to connect
to a single needle | Additional connections (to syringes)
does not pose new concerns as the
ARTHROTAP is intended to be
connected to syringes, which have
the same safety and efficacy
concerns as the ANUTRA syringe.
Both devices are intended to be
connected to a needle, which has no
new concerns. |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Operation /
Actuation
method | Pressing the sliding
rod horizontally to
open and close fluid
paths by means of
moving sliding seals
within the device. | Pressing or pulling
the sliding rod
vertically to move the
sliding seal within the
device to compress
or expand hollow
space inside cylinder. | The method of operation for both
devices involves moving sliding
seals within the device by means of
pressing (or pulling) on a sliding rod.
There are no new safety or efficacy
concerns, as the method of sealing
is the same (sliding seals), and the
method of operation is very similar. |
| Calibration | The ARTHROTAP is
a pass-through
device, is not
calibrated for
volume, and does
not have graduated
markings. | ls calibrated, and has
graduated markings | There are no new safety or efficacy
concerns with the ARTHROTAP as
the device is a pass-through device
and does not require calibration or
graduated markings. (For
procedures where graduated
markings are required, users can
attach a calibrated syringe to the
ARTHROTAP). |
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]
8
- 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 (Pyrogenicity)
- . USP 40 Bacterial Endotoxin (LAL)
- USP 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
9
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 (