The Distal Access Catheter is a single lumen, flexible, variable stiffness composite catheter which has a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. The Distal Access Catheter has a radiopaque marker on the distal tip that is visible under fluoroscopy. The Distal Access Catheter inner lumen can accommodate guidewires up to 0.038 inches in diameter to aid in placement of the catheter system. The catheter has a straight tip. The catheter is offered in various lengths to accommodate physician preferences and anatomical variations. The catheter is provided sterile, nonpyrogenic, and is intended for single use only.

AI/ML Overview

The provided text describes information for a Distal Access Catheter, specifically related to its 510(k) premarket notification for FDA clearance. It details the device's characteristics, intended use, and comparisons to a predicate device, along with non-clinical performance testing (bench testing, biocompatibility, sterility, and shelf-life).

However, the prompt asks for acceptance criteria and a study that proves a device meets acceptance criteria, with specific questions related to AI/Machine Learning (ML) performance, such as:

A table of acceptance criteria and the reported device performance.
Sample size used for the test set and data provenance.
Number of experts used to establish ground truth and their qualifications.
Adjudication method for the test set.
If a multi-reader, multi-case (MRMC) comparative effectiveness study was done and its effect size.
If a standalone (algorithm only) performance study was done.
The type of ground truth used.
The sample size for the training set.
How the ground truth for the training set was established.

The provided FDA 510(k) document is for a physical medical device (catheter) and does NOT describe any AI/ML components or studies. Therefore, it does not contain the information necessary to answer the questions about AI/ML acceptance criteria, test sets, ground truth establishment, or clinical studies involving AI.

Based on the provided document, here is a summary of acceptance criteria and performance for the physical device:

Acceptance Criteria and Device Performance (for the physical catheter)

1. A table of acceptance criteria and the reported device performance

The document lists various non-clinical (bench) tests and biocompatibility tests. The "Result" column effectively indicates whether the device met the pre-defined acceptance criteria for each test.

Test	Test Method Summary	Acceptance Criteria (Implied by Result) & Reported Device Performance
Bench Testing
Dimensional Verification	Measured effective length, inner diameter (proximal/distal), max outer diameter.	Device met the dimensional specifications. (Implied acceptance: within specified dimensions)
Visual Inspection	Inspected for structural or mechanical damage.	Device met the visual specifications. (Implied acceptance: no structural/mechanical damage)
Simulated Use and Compatibility Testing	Simulated clinical use with compatible devices in a tortuous anatomical bench test model.	Device performed as intended under simulated use conditions. (Implied acceptance: performed as expected)
Delivery and Retrieval	Measured maximum forces to deliver and retrieve device through tortuous anatomical bench model.	Device met the delivery and retrieval force specifications. (Implied acceptance: forces within specification)
Tensile Strength	Tested peak tensile force of all bonding points using a universal tensile machine per ISO 10555-1.	Device met acceptance criteria determined with delivery and retrieval force testing. (Implied acceptance: passed)
Torque Strength	Devices pre-conditioned and torqued to failure inside tortuous anatomical model with distal tip held fixed.	Device torque strength is similar to the predicate. (Implied acceptance: comparable to predicate)
Burst Pressure	Evaluated per ISO 10555-1:2013 following pre-conditioning.	Device resistance to burst pressure is similar to the predicate. (Implied acceptance: comparable to predicate)
Kink Resistance	Devices pre-conditioned and bonding points wrapped around varying size pin gauges until failure.	Device kink resistance is similar to the predicate. (Implied acceptance: comparable to predicate)
Coating Integrity	Hydrophilic coating on catheter surface evaluated after particulate testing for defects.	Device coating integrity is similar to the predicate. (Implied acceptance: comparable to predicate)
Corrosion Resistance	Evaluated per ISO 10555-1:2013.	Device met corrosion resistance specification. (Implied acceptance: passed)
Air Leakage	Evaluated per ISO 10555-1:2013 following pre-conditioning.	Device integrity is suitable for intended clinical use and met requirements of ISO 10555-1. (Implied acceptance: passed)
Liquid Leakage	Evaluated per ISO 10555-1:2013 following pre-conditioning.	Device integrity is suitable for intended clinical use and met requirements of ISO 10555-1. (Implied acceptance: passed)
Radiopacity	Visibility of distal marker band and catheter body evaluated under X-ray.	Device radiopacity comparable to the predicate device. (Implied acceptance: comparable to predicate)
Particulate Testing	Test articles tracked multiple times through tortuous anatomical model with ancillary devices; particulates collected.	Particulate generation of the subject device was comparable to the predicate device. (Implied acceptance: comparable to predicate)
Luer Connector Testing	Evaluated per ISO 80369-7 and ISO 80369-20.	Device met the establish acceptance criteria. (Implied acceptance: passed)
Tip Flexibility and Tip Buckling Testing	Catheter distal tip evaluated following simulated use testing.	Tip flexibility and tip buckling of the subject device are similar to the predicate device. (Implied acceptance: comparable to predicate)
Biocompatibility
Cytotoxicity	ISO 10993-5:2009 MTT Method.	The Distal Access Catheter, introducer sheath, and shaping mandrel were non-cytotoxic. (Implied acceptance: non-cytotoxic)
Skin Sensitization	ISO 10993-10:2021 Guinea Pig Maximization Test.	The Distal Access Catheter, introducer sheath, and shaping mandrel were non-sensitizers. (Implied acceptance: non-sensitizing)
Irritation	ISO 10993-23:2021 Intracutaneous Reactivity Test.	The Distal Access Catheter, introducer sheath, and shaping mandrel were non-irritant. (Implied acceptance: non-irritant)
Acute Systemic Toxicity	ISO 10993-11:2017 Acute Systemic Toxicity Study in Mice.	No mortality or evidence of acute systemic toxicity with the Distal Access Catheter, introducer sheath, and shaping mandrel test articles. (Implied acceptance: passed)
Material-Mediated Pyrogenicity	USP <151>, ISO 10993-11:2017 Rabbit Pyrogen Study.	The Distal Access Catheter, introducer sheath, and shaping mandrel were non-pyrogenic. (Implied acceptance: non-pyrogenic)
Hemocompatibility (Hemolysis)	ASTM F756-2017, ISO 10993-4:2017 ASTM Hemolysis Study (Direct and Indirect Contact).	The Distal Access Catheter was non-hemolytic (direct and indirect contact). The introducer sheath and shaping mandrel were non-hemolytic (indirect contact). (Implied acceptance: non-hemolytic)
Hemocompatibility (Complement Activation)	ISO 10993-4:2017 Complement Activation, SC5b-9.	The Distal Access Catheter results were similar to the negative control group. (Implied acceptance: no abnormal activation)
Hemocompatibility (Partial Thromboplastin	ISO 10993-4:2017, ASTM F2382-2018 Partial Thromboplastin Time Study.	The Distal Access Catheter results were similar to the negative control group. (Implied acceptance: no abnormal effect on clotting)
Hemocompatibility (Thromboresistance)	ISO 10993-4:2017 In Vivo Vein Thromboresistance Study.	The Distal Access Catheter results were similar to the control and had no evidence of thrombosis. (Implied acceptance: no thrombosis)
Genotoxicity (Bacterial Reverse Mutation)	ISO 10993-3:2014 Bacterial Reverse Mutation Test.	No backward mutation in Salmonella typhimurium with the Distal Access Catheter test article. (Implied acceptance: non-mutagenic)
Genotoxicity (Mouse Lymphoma TK Assay)	ISO 10993-3:2014 Mouse Lymphoma TK Assay.	The Distal Access Catheter was non-mutagenic to mouse lymphoma cells (L5178Y TK+/--3.7.2C). (Implied acceptance: non-mutagenic)
Genotoxicity (Chromosome Aberration Test)	ISO 10993-3:2014 In vitro Mammalian Chromosome Aberration Test.	The Distal Access Catheter results were similar to the negative control group. (Implied acceptance: no abnormal chromosomal aberration)
Sterility	Sterilization process validated per ISO 11135:2014.	Sterility Assurance Level (SAL) of 10^-4 achieved. EO and ECH residuals below ISO 10993-7:2008 limits. Bacterial Endotoxin Levels < 2.15 EU/device (USP <85>).
Shelf-life	Baseline and accelerated shelf-life testing.	Demonstrated the device will perform as intended to support the proposed 1-year shelf-life. (Implied acceptance: meets 1-year shelf-life stability)

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes bench testing and biocompatibility testing only. It does not mention any clinical data, patient data, retrospective, or prospective studies.
The sample sizes for these tests are not explicitly stated in numerical values (e.g., "n=X units were tested"), but implied by "test articles," "devices," or descriptions like "all bonding points."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is irrelevant for the provided document as it concerns a physical catheter, not an AI/ML product requiring "ground truth" from experts interpreting medical images or data. The "ground truth" for this device's performance is established by objective engineering and biocompatibility test standards and measurements.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is irrelevant for the provided document as it concerns a physical catheter, not an AI/ML product requiring clinical adjudication of interpretations.

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

No MRMC or any clinical effectiveness studies were performed or described. The document explicitly states: "No clinical studies were deemed necessary to demonstrate substantial equivalence."

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

Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the physical device, the "ground truth" is defined by established engineering standards (e.g., ISO standards), physical measurements, chemical analyses, and biological assays. It's not based on expert clinical consensus or pathology in the context of diagnostic interpretation.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML product that undergoes "training."

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

Not applicable. This is a physical device, not an AI/ML product.

Summary

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January 19, 2024

Image /page/0/Picture/1 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 features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

AccuMedical Beijing Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai. 200120 China

Re: K231218

Trade/Device Name: Distal Access Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY Dated: December 21, 2023 Received: December 22, 2023

Dear Diana Hong:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Naira Muradyan -S

Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K231218

Device Name Distal Access Catheter

Indications for Use (Describe)

The Distal Access Catheter is indicated for the introduction of interventional devices into the peripheral and neurovasculature.

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 contains a logo for a company called ACCUMEDICAL. The logo consists of a series of blue concentric circles on the left, followed by the company name in both Chinese and English. The Chinese characters are placed above the English name, with a vertical line separating the circles from the text.

K231218 510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of 21 CFR 807.92.

1. Date of Preparation: 01/19/2024
1. Sponsor Identification

AccuMedical Beijing Ltd.

3rd Floor, Building 9, No.1, Caida 3rd Street, Shunyi District, Beijing, China.

Contact Person: Dawei Long Title: RA Manager Tel: +86-15301031815 Email: dawei.long@accumedicalcorp.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Ms. Tingting Su (Alternative Contact Person)

Mid-Link Consulting Co., Ltd

P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850 Fax: 360-925-3199 Email: info@mid-link.net

1. Identification of Proposed Device
  Trade Name: Distal Access Catheter Common Name: Percutaneous Catheter

Regulatory Information Classification Name: Catheter, Percutaneous, Neurovasculature Classification: II Primary Product Code: QJP Regulation Number: 21 CFR 870.1250 Review Panel: Neurology

Classification Name: Catheter, Percutaneous Classification: II Secondary Product Code: DQY

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Image /page/4/Picture/0 description: The image contains a logo for a company called ACCUMEDICAL. The logo consists of a series of blue concentric circles on the left, followed by the company name in both Chinese and English. The Chinese characters are placed above the English name, with a vertical line separating the circles from the text.

Regulation Number: 21 CFR 870.1250 Review Panel: Cardiovascular

1. Indications for Use
  The Distal Access Catheter is indicated for the introduction of interventional devices into the peripheral and neurovasculature.
Device Description 6.
The Distal Access Catheter is a single lumen, flexible, variable stiffness composite catheter which has a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. The Distal Access Catheter has a radiopaque marker on the distal tip that is visible under fluoroscopy. The Distal Access Catheter inner lumen can accommodate guidewires up to 0.038 inches in diameter to aid in placement of the catheter system. The catheter has a straight tip. The catheter is offered in various lengths to accommodate physician preferences and anatomical variations. The catheter is provided sterile, nonpyrogenic, and is intended for single use only.
1. Identification of the Predicate Device
  510(k) Number: K161152 Device Name: Navien™ Intracranial Support Catheter

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Image /page/5/Picture/0 description: The image shows the logo for Accumedical. The logo consists of a blue circular design on the left, followed by the text "艾柯医疗" in gray. Below this text is the word "ACCUMEDICAL" also in gray. The logo appears to be for a medical company.

8. Comparison of Technological Characteristics

Item	Subject Device (K231218)	Predicate Device (K161152)
	Distal Access Catheter	Navien Intracranial Support Catheter
Classification	II	II
Product Code	QJP, DQY	DQY
Regulation Number	21 CFR 870.1250	21 CFR 870.1250
Indications for Use	The Distal Access Catheter is indicated for the introduction of interventional devices into the peripheral and neurovasculature.	The Navien™ Intracranial Support Catheter is indicated for the introduction of interventional devices into the peripheral and neurovasculature.
Accessories	Shaping MandrelTwo Peelable Introducer Sheaths	None
Distal Inner Diameter (ID)	1.80 mm (0.071")	0.046" – 0.072"
Distal Outer Diameter (OD)	2.13 mm (0.084")	0.058"– 0.084" max
Proximal ID	1.80 mm (0.071")	0.046" – 0.072"
Proximal OD	2.13 mm (0.084")	0.058"– 0.084" max
Effective Length	90 - 138 cm	90 - 130 cm
Maximum Guidewire OD	0.038 inch	0.038 inch
Radiopaque Marker	Yes	Yes
Tip Configuration	Single, straight flexible tip	Single, straight flexible tip
Coating	Hydrophilic coating	Hydrophilic coating
Single Use	Yes	Yes
Sterilization	Ethylene oxide	Ethylene oxide
Sterility Assurance Level	10-6	10-6
Packaging	Catheter in packaging coil attached to packaging card inside PET/ LDPE/ Tyvek pouch inside white card carton.	Catheter in polyethylene hoop attached to packaging card inside PET/PE/Tyvek pouch inside SBS carton.
Shelf-Life	1 year	2 years
Materials:
Catheter Outer Layer	TPU, Pebax, Polyamide	PTFE lined polymeric catheter.
Shaft Inner Layer	PTFE	Catheter shaft support - Nitinol.
Hub	Polyamide	Unknown
Shaping Mandrel	304 Stainless Steel	None
Peelable Introducer	PTFE	None
Sheath	Pebax	Unknown
Strain Relief	Pebax	Unknown

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Image /page/6/Picture/0 description: The image shows the logo for Accumedical. The logo consists of a series of overlapping blue circles on the left, followed by the text "艾柯医疗" in Chinese and "ACCUMEDICAL" in English. The text is in a gray sans-serif font.

1. Non-Clinical Performance Testing

Bench Testing

Bench performance testing was conducted to verify that the Distal Access Catheter meets all design specifications and to support substantial equivalence to the predicate.

The results of performance testing conducted on the Distal Access Catheter demonstrate that it performs as intended and is substantially equivalent to the predicate. A summary of the tests performed is provided in the table below:

Test	Test Method Summary	Result
DimensionalVerification	The effective length of the catheter shaft, theinner diameter of the proximal and distal endsof the catheter shaft, and the maximum outerdiameter of the entire catheter shaft wasmeasured.	Device met the dimensionalspecifications.
Visual Inspection	The catheter was inspected for structural ormechanical damage.	Device met the visualspecifications.
Simulated Use andCompatibilityTesting	Clinical use was simulated with compatibledevices in a tortuous anatomical bench testmodel to test compatibility.	Device performed asintended under simulated useconditions.
Delivery andRetrieval	The maximum forces to deliver and retrieve thedevice through a tortuous anatomical bench testmodel were measured.	Device met the delivery andretrieval force specifications.
Tensile Strength	Devices were pre-conditioned by simulateduse. The peak tensile force of all bondingpoints of the catheter was tested using auniversal tensile machine per methods definedin ISO 10555-1.	Device met acceptancecriteria determined withdelivery and retrieval forcetesting.
Torque Strength	Devices were pre-conditioned by simulated useand torqued to failure inside tortuousanatomical model with distal tip held fixed.	Device torque strength issimilar to the predicate.
Burst Pressure	The catheter was evaluated per methodsdefined in ISO 10555-1:2013 following pre-conditioning by simulated use.	Device resistance to burstpressure is similar to thepredicate.
Kink Resistance	Devices were pre-conditioned by simulated useand all bonding points of the distal accesscatheter were wrapped around varying size pingauges until failure.	Device kink resistance issimilar to the predicate.
Coating Integrity	Hydrophilic coating on the catheter surface wasevaluated after particulate testing for defects.	Device coating integrity issimilar to the predicate.

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Image /page/7/Picture/0 description: The image shows the logo for ACCUMEDICAL. The logo consists of a series of blue circles on the left, followed by the text "ACCUMEDICAL" in gray. To the right of the circles, there are also three Chinese characters in gray.

Corrosion Resistance	The subject device was evaluated per ISO 10555-1:2013 to demonstrate that the device meets the corrosion resistance requirements.	Device met corrosion resistance specification.
Air Leakage	The subject device was evaluated per methods and criteria defined in ISO 10555-1:2013 following pre-conditioning by simulated use.	Device integrity is suitable for intended clinical use and met requirements of ISO 10555-1.
Liquid Leakage	The subject device was evaluated per methods and criteria defined in ISO 10555-1:2013 following pre-conditioning by simulated use.	Device integrity is suitable for intended clinical use and met requirements of ISO 10555-1.
Radiopacity	Visibility of the distal marker band and catheter body were evaluated under X-ray.	Device radiopacity comparable to the predicate device.
Particulate Testing	Test articles were tracked multiple times through a tortuous anatomical model with ancillary devices and all generated particulates were collected.	Particulate generation of the subject device was comparable to the predicate device.
Luer Connector Testing	The subject device was evaluated per ISO 80369-7 and ISO 80369-20 to demonstrate that the device meets the requirements.	Device met the establish acceptance criteria.
Tip Flexibility and Tip Buckling Testing	The catheter distal tip was evaluated following simulated use testing.	Tip flexibility and tip buckling of the subject device are similar to the predicate device

Biocompatibility

The Distal Access Catheter is categorized as Externally Communicating Device, Circulating Blood, Limited Contact (≤ 24 hours). The introducer sheath and shaping mandrel are considered to have indirect blood contact for a limited (≤ 24 hours) duration, via the fluid path and solid-to-solid contact, respectively. Per ISO 10993-1, the following tests were conducted on the final, finished device based on the nature and duration of tissue contact:

Test	Test Method Summary	Conclusion
Cytotoxicity	ISO 10993-5:2009MTT Method	The Distal Access Catheter, introducersheath, and shaping mandrel were non-cytotoxic.
	Skin Sensitization	ISO 10993-10:2021Guinea Pig Maximization Test	The Distal Access Catheter, introducersheath, and shaping mandrel were non-sensitizers.

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Image /page/8/Picture/0 description: The image shows the logo for Accumedical. The logo consists of a series of blue circles that are connected to each other. To the right of the circles is the text "艾柯医疗" in Chinese characters, followed by the word "ACCUMEDICAL" in English. The text is in a gray sans-serif font.

Irritation	ISO 10993-23:2021Intracutaneous Reactivity Test	The Distal Access Catheter, introducer sheath, and shaping mandrel were non-irritant.
Acute Systemic Toxicity	ISO 10993-11:2017Acute Systemic Toxicity Study in Mice	No mortality or evidence of acute systemic toxicity with the Distal Access Catheter, introducer sheath, and shaping mandrel test articles.
Material-Mediated Pyrogenicity	USP <151>, ISO 10993-11:2017Rabbit Pyrogen Study	The Distal Access Catheter, introducer sheath, and shaping mandrel were non-pyrogenic.
Hemocompatibility	ASTM F756-2017, ISO 10993-4:2017ASTM Hemolysis Study (Direct and Indirect Contact)	The Distal Access Catheter was non-hemolytic (direct and indirect contact).The introducer sheath and shaping mandrel were non-hemolytic (indirect contact).
	ISO 10993-4:2017Complement Activation, SC5b-9	The Distal Access Catheter results were similar to the negative control group.
	ISO 10993-4:2017, ASTM F2382-2018Partial Thromboplastin Time Study	The Distal Access Catheter results were similar to the negative control group.
	ISO 10993-4:2017In Vivo Vein Thromboresistance Study	The Distal Access Catheter results were similar to the control and had no evidence of thrombosis.
Genotoxicity	ISO 10993-3:2014Bacterial Reverse Mutation Test	No backward mutation in Salmonella typhimurium with the Distal Access Catheter test article.
	ISO 10993-3:2014Mouse Lymphoma TK Assay	The Distal Access Catheter was non-mutagenic to mouse lymphoma cells (L5178Y TK+/--3.7.2C).
	ISO 10993-3:2014In vitro Mammalian Chromosome Aberration Test	The Distal Access Catheter results were similar to the negative control group.

Sterility and Shelf-life

The Distal Access Catheter sterilization process using Ethylene Oxide (EO) has been validated in accordance with ISO 11135:2014 to achieve a sterility assurance level (SAL) of 104. EO and Ethylene Chlorohydrin (ECH) residuals were below the limits specified in ISO 10993-7:2008. Bacterial Endotoxin Levels were below the level of 2.15 EU/device in accordance with USP <85>. Both baseline and accelerated shelf-life testing were conducted demonstrating the device will perform as intended to support the proposed 1-year shelf-life.

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Image /page/9/Picture/0 description: The image contains a logo for a medical company. The logo features a series of blue circles that are connected to a vertical blue line. To the right of the blue line, the text "ACCUMEDICAL" is written in gray. Above the word "ACCUMEDICAL", there are two Chinese characters.

10. Clinical Performance Testing

No clinical studies were deemed necessary to demonstrate substantial equivalence.

11. Conclusion

The subject device, Distal Access Catheter, has similar technological characteristics and the same intended use as the predicate device, Navien Intracranial Support Catheter (K161152). The differences in technological characteristics do not raise new or different questions of safety or effectiveness. Based on the completed bench performance, biocompatibility, and sterility testing, and the comparison and analysis above, the subject device performs as intended and is determined to be substantially equivalent to the predicate device.

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).