(266 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is a catheter for introducing other interventional devices, not for directly treating a condition.
No
Explanation: The device is a catheter used for the introduction of interventional devices, not for diagnosing medical conditions.
No
The device description clearly details a physical catheter with a lumen, luer hub, hydrophilic coating, radiopaque marker, and varying lengths, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the introduction of interventional devices into the peripheral and neurovasculature. This describes a device used in vivo (within the body) for a procedural purpose, not for testing samples in vitro (outside the body).
- Device Description: The description details a catheter designed for insertion into blood vessels, with features like a lumen for guidewires, a hydrophilic coating, and a radiopaque marker for visualization during a procedure. These are characteristics of a medical device used directly on a patient.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information based on such analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely procedural and interventional.
N/A
Intended Use / Indications for Use
The Distal Access Catheter is indicated for the introduction of interventional devices into the peripheral and neurovasculature.
Product codes
QJP, DQY
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy (for radiopaque marker visibility)
Anatomical Site
Peripheral and neurovasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Bench Testing:
- Test: Dimensional Verification, Result: Device met the dimensional specifications.
- Test: Visual Inspection, Result: Device met the visual specifications.
- Test: Simulated Use and Compatibility Testing, Result: Device performed as intended under simulated use conditions.
- Test: Delivery and Retrieval, Result: Device met the delivery and retrieval force specifications.
- Test: Tensile Strength, Result: Device met acceptance criteria determined with delivery and retrieval force testing.
- Test: Torque Strength, Result: Device torque strength is similar to the predicate.
- Test: Burst Pressure, Result: Device resistance to burst pressure is similar to the predicate.
- Test: Kink Resistance, Result: Device kink resistance is similar to the predicate.
- Test: Coating Integrity, Result: Device coating integrity is similar to the predicate.
- Test: Corrosion Resistance, Result: Device met corrosion resistance specification.
- Test: Air Leakage, Result: Device integrity is suitable for intended clinical use and met requirements of ISO 10555-1.
- Test: Liquid Leakage, Result: Device integrity is suitable for intended clinical use and met requirements of ISO 10555-1.
- Test: Radiopacity, Result: Device radiopacity comparable to the predicate device.
- Test: Particulate Testing, Result: Particulate generation of the subject device was comparable to the predicate device.
- Test: Luer Connector Testing, Result: Device met the establish acceptance criteria.
- Test: Tip Flexibility and Tip Buckling Testing, Result: Tip flexibility and tip buckling of the subject device are similar to the predicate device.
Biocompatibility (for Externally Communicating Device, Circulating Blood, Limited Contact (≤ 24 hours)):
- Test: Cytotoxicity (ISO 10993-5:2009 MTT Method), Conclusion: The Distal Access Catheter, introducer sheath, and shaping mandrel were non-cytotoxic.
- Test: Skin Sensitization (ISO 10993-10:2021 Guinea Pig Maximization Test), Conclusion: The Distal Access Catheter, introducer sheath, and shaping mandrel were non-sensitizers.
- Test: Irritation (ISO 10993-23:2021 Intracutaneous Reactivity Test), Conclusion: The Distal Access Catheter, introducer sheath, and shaping mandrel were non-irritant.
- Test: Acute Systemic Toxicity (ISO 10993-11:2017 Acute Systemic Toxicity Study in Mice), Conclusion: No mortality or evidence of acute systemic toxicity with the Distal Access Catheter, introducer sheath, and shaping mandrel test articles.
- Test: Material-Mediated Pyrogenicity (USP , ISO 10993-11:2017 Rabbit Pyrogen Study), Conclusion: The Distal Access Catheter, introducer sheath, and shaping mandrel were non-pyrogenic.
- Test: Hemocompatibility (ASTM F756-2017, ISO 10993-4:2017 ASTM Hemolysis Study (Direct and Indirect Contact)), Conclusion: The Distal Access Catheter was non-hemolytic (direct and indirect contact). The introducer sheath and shaping mandrel were non-hemolytic (indirect contact).
- Test: Hemocompatibility (ISO 10993-4:2017 Complement Activation, SC5b-9), Conclusion: The Distal Access Catheter results were similar to the negative control group.
- Test: Hemocompatibility (ISO 10993-4:2017, ASTM F2382-2018 Partial Thromboplastin Time Study), Conclusion: The Distal Access Catheter results were similar to the negative control group.
- Test: Hemocompatibility (ISO 10993-4:2017 In Vivo Vein Thromboresistance Study), Conclusion: The Distal Access Catheter results were similar to the control and had no evidence of thrombosis.
- Test: Genotoxicity (ISO 10993-3:2014 Bacterial Reverse Mutation Test), Conclusion: No backward mutation in Salmonella typhimurium with the Distal Access Catheter test article.
- Test: Genotoxicity (ISO 10993-3:2014 Mouse Lymphoma TK Assay), Conclusion: The Distal Access Catheter was non-mutagenic to mouse lymphoma cells (L5178Y TK+/--3.7.2C).
- Test: Genotoxicity (ISO 10993-3:2014 In vitro Mammalian Chromosome Aberration Test), Conclusion: The Distal Access Catheter results were similar to the negative control group.
Sterility and Shelf-life:
- Sterilization process using Ethylene Oxide (EO) validated in accordance with ISO 11135:2014 to achieve a sterility assurance level (SAL) of 10-4.
- EO and Ethylene Chlorohydrin (ECH) residuals were below limits specified in ISO 10993-7:2008.
- Bacterial Endotoxin Levels were below 2.15 EU/device in accordance with USP .
- Both baseline and accelerated shelf-life testing were conducted demonstrating the device will perform as intended to support the proposed 1-year shelf-life.
Clinical Performance Testing:
- No clinical studies were deemed necessary to demonstrate substantial equivalence.
Key Results: The device performs as intended and is substantially equivalent to the predicate based on bench performance, biocompatibility, and sterility testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found (Performance metrics are related to the physical and biological characteristics of the catheter, not diagnostic accuracy).
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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).
1
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
2
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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3
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.
-
- Date of Preparation: 01/19/2024
-
- 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
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Tingting Su (Alternative Contact Person)
- Designated Submission Correspondent
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
-
- Identification of Proposed Device
Trade Name: Distal Access Catheter Common Name: Percutaneous Catheter
- Identification of Proposed Device
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
4
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
-
- Indications for Use
The Distal Access Catheter is indicated for the introduction of interventional devices into the peripheral and neurovasculature.
- Indications for Use
-
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. -
- Identification of the Predicate Device
510(k) Number: K161152 Device Name: Navien™ Intracranial Support Catheter
- Identification of the Predicate Device
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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 Mandrel | |
| Two 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.
-
- 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 |
|---|---|---|
| Dimensional | ||
| Verification | The effective length of the catheter shaft, the | |
| inner diameter of the proximal and distal ends | ||
| of the catheter shaft, and the maximum outer | ||
| diameter of the entire catheter shaft was | ||
| measured. | Device met the dimensional | |
| specifications. | ||
| Visual Inspection | The catheter was inspected for structural or | |
| mechanical damage. | Device met the visual | |
| specifications. | ||
| Simulated Use and | ||
| Compatibility | ||
| Testing | Clinical use was simulated with compatible | |
| devices in a tortuous anatomical bench test | ||
| model to test compatibility. | Device performed as | |
| intended under simulated use | ||
| conditions. | ||
| Delivery and | ||
| Retrieval | The maximum forces to deliver and retrieve the | |
| device through a tortuous anatomical bench test | ||
| model were measured. | Device met the delivery and | |
| retrieval force specifications. | ||
| Tensile Strength | Devices were pre-conditioned by simulated | |
| use. The peak tensile force of all bonding | ||
| points of the catheter was tested using a | ||
| universal tensile machine per methods defined | ||
| in ISO 10555-1. | Device met acceptance | |
| criteria determined with | ||
| delivery and retrieval force | ||
| testing. | ||
| Torque Strength | Devices were pre-conditioned by simulated use | |
| and torqued to failure inside tortuous | ||
| anatomical model with distal tip held fixed. | Device torque strength is | |
| similar to the predicate. | ||
| Burst Pressure | The catheter was evaluated per methods | |
| defined in ISO 10555-1:2013 following pre- | ||
| conditioning by simulated use. | Device resistance to burst | |
| pressure is similar to the | ||
| predicate. | ||
| Kink Resistance | Devices were pre-conditioned by simulated use | |
| and all bonding points of the distal access | ||
| catheter were wrapped around varying size pin | ||
| gauges until failure. | Device kink resistance is | |
| similar to the predicate. | ||
| Coating Integrity | Hydrophilic coating on the catheter surface was | |
| evaluated after particulate testing for defects. | Device coating integrity is | |
| similar 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 10993-5:2009 | ||
| MTT Method | The Distal Access Catheter, introducer | ||
| sheath, and shaping mandrel were non- | |||
| cytotoxic. | |||
| Skin Sensitization | ISO 10993-10:2021 | ||
| Guinea Pig Maximization Test | The Distal Access Catheter, introducer | ||
| sheath, 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 10993-23:2021
Intracutaneous Reactivity Test | The Distal Access Catheter, introducer sheath, and shaping mandrel were 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. |
| Material-Mediated Pyrogenicity | USP , ISO 10993-11:2017
Rabbit Pyrogen Study | The Distal Access Catheter, introducer sheath, and shaping mandrel were non-pyrogenic. |
| Hemocompatibility | 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). |
| | ISO 10993-4:2017
Complement Activation, SC5b-9 | The Distal Access Catheter results were similar to the negative control group. |
| | ISO 10993-4:2017, ASTM F2382-2018
Partial Thromboplastin Time Study | The Distal Access Catheter results were similar to the negative control group. |
| | 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. |
| Genotoxicity | ISO 10993-3:2014
Bacterial Reverse Mutation Test | No backward mutation in Salmonella typhimurium with the Distal Access Catheter test article. |
| | ISO 10993-3:2014
Mouse Lymphoma TK Assay | The Distal Access Catheter was non-mutagenic to mouse lymphoma cells (L5178Y TK+/--3.7.2C). |
| | ISO 10993-3:2014
In 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 . 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.