(330 days)
The Balloon Guiding Catheter is intended to assist intravascular catheterization and guidance of an intravascular catheter into a selected vessel in the neuro or peripheral vascular system. The balloon can provide temporary vascular occlusion during angiography.
The proposed device, Balloon Guiding Catheter, is a braid-reinforced, variable stiffness catheter designed for use in facilitating the guidance of an intravascular catheter into a target vessel in the neuro or peripheral vascular system. A radiopaque marker is included on the distal end for angiographic visualization. A compliant balloon is mounted on the distal end to provide temporary vascular occlusion during angiographic procedures. The proposed device is divided into the S and S+ types with different effective lengths, the difference between S type is the size of the catheter.
The provided document is a 510(k) summary for a medical device called a "Balloon Guiding Catheter." It describes the device, its intended use, a comparison to a predicate device, and the non-clinical testing performed to establish substantial equivalence.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria (Implied/Stated) | Reported Device Performance |
|---|---|---|
| Non-Clinical/Performance Testing | ||
| Dimensional Verification | Met specified measurements | Size verification met acceptance criteria. |
| Radiopacity | Visible under X-ray | The radiopaque marker on the catheter tip is visible under X-ray. |
| Torque Testing | Capable of rotation without catheter body damage or bending | The catheter body is not damaged and bent. |
| Balloon Compliance | (Implied: proper expansion with varying liquid volumes) | Compliant. |
| Balloon Expansion/Contraction Time | Met specified times | Balloon expansion and contraction times met acceptance criteria. |
| Balloon Fatigue Test | No balloon leakage or damage after 20 expansions/contractions | The balloon is not leaking or damaged. |
| Balloon Volume Limit | No balloon leakage or damage after 2.5x limit volume injection | The balloon is not leaking or damaged. |
| Peak Tensile Force | Met acceptance criteria | Peak tensile force met acceptance criteria. |
| Catheter Bond Strength | Met acceptance criteria | Catheter bond strength met acceptance criteria. |
| Compatibility Test | Usable as intended with compatible devices in a vascular model | The device can be used as intended. |
| Anti-collapse Test | Compatible devices do not experience increased blocking; catheter does not collapse | Compatible devices do not experience increased blocking during push and retracement, and the catheter did not collapse. |
| Burst Pressure | Met acceptance criteria (greater than manual syringe injection pressures) | Burst pressure met acceptance criteria. |
| Kink Resistance | Met acceptance criteria (per FDA guidance) | Kink resistance met acceptance criteria. |
| Air Leakage | No air leakage (per ISO 10555-1) | No air leakage. |
| Liquid Leakage | No liquid leakage (per ISO 10555-1) | No liquid leakage. |
| Particulate Testing | Number and size of particles similar to comparator device | The number and size of the particles were similar to that of the comparator device. |
| Connector Performance | Met requirements for small bore connectors (per ISO 594-1 & 594-2) | Connector performance met acceptance criteria. |
| Biocompatibility Testing | ||
| Cytotoxicity | Non-cytotoxic (viability > 70% of blank) | Non-cytotoxic. |
| Irritation | No irritation | No irritation. |
| Sensitization | No sensitization | No sensitization. |
| Systemic Toxicity | No abnormal clinical signs indicative of toxicity | No systemic toxicity. |
| Hemolysis | Non-hemolytic (difference from negative control evaluated) | Non-hemolytic. |
| Material Mediated Pyrogenicity | Nonpyrogenic (no temperature rise in study animals) | Nonpyrogenic. |
| In Vivo Thromboresistance | Meet predetermined acceptance criteria (test score is 0, i.e., No thrombosis) | Meet the predetermined acceptance criteria, the test score is 0, i.e., No thrombosis. |
| Complement Activation | No statistical difference from the predicate device | No statistical difference from the predicate device. |
| Partial Thromboplastin Time | No difference from predicate device clotting time | No difference from predicate device. |
| Sterilization & Shelf Life | ||
| Sterility Assurance Level (SAL) | 10-6 (per ISO 11135-1:2014) | SAL of 10-6 achieved. |
| EO and ECH residuals | Below limits specified in ISO 10993-7:2008 | Below the limits specified in ISO 10993-7:2008. |
| Bacterial Endotoxin Levels | Below 2.15 EU/device (per USP <85>) | Below the level of 2.15 EU/device. |
| Shelf-life | Perform as intended for 2 years | Device will perform as intended to support the proposed 2-year shelf-life. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample sizes used for each individual non-clinical test. It generally states that "Non-clinical tests were conducted to verify that the proposed device met all design specifications."
- Sample Size: Not explicitly stated for each test.
- Data Provenance: The tests are non-clinical (benchtop and in vitro/in vivo biocompatibility). The document does not specify country of origin for the data; however, the manufacturer is Shanghai Heartcare Medical Technology Co., Ltd. in China, implying testing was likely conducted or commissioned by them. The studies are retrospective in the sense that they are conducted on finished or pilot-production devices to demonstrate performance against specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. This device is a physical medical instrument, not an AI/software device requiring expert consensus for ground truth on a dataset. The "ground truth" for the non-clinical tests is established by objective measurements against established engineering specifications and recognized international standards (e.g., ISO, ASTM, USP).
4. Adjudication Method for the Test Set:
Not applicable. As described above, this is not a study requiring human adjudication of results in the traditional sense of medical image or clinical outcome interpretation.
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:
Not applicable. This is not an AI/software device. No MRMC study was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/software device. No standalone algorithm performance study was performed.
7. The Type of Ground Truth Used:
The "ground truth" for this device's acceptance criteria are based on:
- Engineering Specifications: Defined dimensional tolerances, mechanical properties (tensile strength, burst pressure, kink resistance), and functional performance (balloon expansion, torque, anti-collapse).
- International Standards: Adherence to ISO (e.g., ISO 10993 for biocompatibility, ISO 11135 for sterilization, ISO 594 for connectors, ISO 10555-1 for leakage), ASTM (e.g., for seal strength, dye penetration, hemolysis), and USP (for pyrogen and endotoxin testing) standards.
- Benchtop Test Results: Objective measurements and observations from physical testing in controlled laboratory environments.
- Biological Test Results: In vitro and in vivo testing (on study animals, e.g., for systemic toxicity, thromboresistance) according to ISO standards.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/software device. There is no "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable. This is not an AI/software device.
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August 25, 2021
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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Shanghai Heartcare Medical Technology Co., Ltd. % Dinana Hong General Manager Mid-Link Consulting Co., Ltd. P.O. Box 120-119 Shanghai. 200120 China
Re: K202916
Trade/Device Name: Balloon Guiding Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY Dated: July 16, 2021 Received: July 23, 2021
Dear Dinana 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 (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
{1}------------------------------------------------
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 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 (QS) 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 medical devices and radiation-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,
Xiaolin Zheng, Ph.D. 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
Enclosure
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Indications for Use
510(k) Number (if known) K202916
Device Name Balloon Guiding Catheter
Indications for Use (Describe)
The Balloon Guiding Catheter is intended to assist intravascular catheterization and guidance of an intravascular catheter into a selected vessel in the neuro or peripheral vascular system. The balloon can provide temporary vascular occlusion during angiography.
| 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
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92. 510(k) Number: K202916
- Date of Preparation: 08/24/2021 1.
-
- Sponsor Identification [807.92(a)(1)]
Shanghai Heartcare Medical Technology Co., Ltd.
590 Ruiqing Rd, Building 4, Suite 201, East Zhangjiang High-Tech Park, Shanghai, P.R. China
Contact Person: Zongyu Xue Position: Director of Quality Regulations Tel: +86-18621683501 Fax: +86-21-68798512 Email: zyxue@strokemedical.com
-
- Designated Submission Correspondent Ms.
Diana Hong (Primary Contact Person) Ms. Tingting Su (Alternative Contact Person)
- Designated Submission Correspondent Ms.
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
{4}------------------------------------------------
4. Identification of Proposed Device [807.92(a)(2)]
Trade Name: Balloon Guiding Catheter; Common Name: Percutaneous Catheter; Models: SMBGC-S80; SMBGC-S95; SMBGC-S+80; SMBGC-S+95
Regulatory Information
Primary Product Code: QJP
Classification Name: Catheter, Percutaneous, Neurovasculature Classification: II Regulation Number: 21 CFR 870.1250 Review Panel: Neurology
Secondary Product Code: DQY
Classification Name: Percutaneous Catheter Classification: II Regulation Number: 21 CFR 870.1250 Review Panel: Cardiovascular
Indications for Use [807.92(a)(5)]
The Balloon Guiding Catheter is intended to assist intravascular catheterization and guidance of an intravascular catheter into a selected vessel in the neuro or peripheral vascular system. The balloon can provide temporary vascular occlusion during angiography.
Device Description [807.92(a)(4)]
The proposed device, Balloon Guiding Catheter, is a braid-reinforced, variable stiffness catheter designed for use in facilitating the guidance of an intravascular catheter into a target vessel in the neuro or peripheral vascular system. A radiopaque marker is included on the distal end for angiographic visualization. A compliant balloon is mounted on the distal end to provide temporary vascular occlusion during angiographic procedures. The proposed device is divided into the S and S+ types with different effective lengths, the difference between S type is the size of the catheter.
ડ. Identification of Predicate Device [807.92(a)(3)]
510(k) Number: K122581
Product Name: Modified Balloon Guide Catheter
{5}------------------------------------------------
Predicate Device Comparison [807.92(a)(6)] 6.
The following table provides a comparison of the key characteristics of the Balloon Guiding Catheter to the predicate device.
| ITEM | Proposed DevicePredicate Device | Remark | |
|---|---|---|---|
| K202916 | K122581 | ||
| Device | Balloon Guiding Catheter | Modified Balloon GuideCatheter | |
| Product Code | QJP, DQY | DQY | Analysis 1 |
| Regulation Number | 21 CFR 870.1250 | 21 CFR 870.1250 | Same |
| Class | II | II | Same |
| Indications for Use | The Balloon Guiding Catheter isintended to assist intravascularcatheterization and guidance ofan intravascular catheter into aselected vessel in the neuro orperipheral vascular system. Theballoon can provide temporaryvascular occlusion duringangiography. | The Modified Balloon GuideCatheter is indicated for use infacilitating the insertion andguidance of an intravascularcatheter into a selected bloodvessel in the peripheral andneuro vascular systems. Theballoon provides temporaryvascular occlusion during theseand other angiographicprocedures. The Balloon GuideCatheter is also indicated foruse as a conduit forRetrieval devices. | Analysis 2 |
| Configuration /Components | Balloon | Balloon | Analysis 3 |
| Outer tube | Outer Jacket | ||
| Braided tube | Liner | ||
| Radiopaque ring | Marker Band | ||
| Tip | Distal Tip | ||
| Strain Relief tube | Strain Relief | ||
| Handpiece | Braid | ||
| Guiding sheath tube | Inner Jacket | ||
| Guiding sheath fitting | Luer Hub | ||
| Protective sheath | Peel Away Sheaths | ||
| Extension tube | Luer-Activated Valve | ||
| Hemostasis valve Y | Dilator | ||
| Needleless injection site | Rotating Hemostasis Valve | ||
| / | Tuohy Borst Valve with side |
| Table 1 Comparison of Technological Characteristics | ||
|---|---|---|
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510K summary
| port | ||||
|---|---|---|---|---|
| Operation Mode | For manual use only | For manual use only | Same | |
| Sterility | Sterile product | Sterile product | Same | |
| Single Use | Yes | Yes | Same | |
| Catheter | O.D. | SMBGC-S80: $2.6\pm0.5$ mmSMBGC-S95: $2.6\pm0.5$ mmSMBGC-S+80: $3.0\pm0.5$ mmSMBGC-S+95: $3.0\pm0.5$ mm | 2.7mm (8F) | Analysis 4 |
| I.D. | SMBGC-S80: $1.98\pm0.06$ mmSMBGC-S95: $1.98\pm0.06$ mmSMBGC-S+80: $2.25\pm0.06$ mmSMBGC-S+95: $2.25\pm0.06$ mm | 2.1mm (6.4F) | ||
| E.L. | SMBGC-S80: $80\pm5$ cmSMBGC-S95: $95\pm5$ cmSMBGC-S+80: $80\pm5$ cmSMBGC-S+95: $95\pm5$ cm | 100cm and 90cm | ||
| Balloon | Max filling agent volume | 0.6 ml | Unknown | Analysis 5 |
| Max diameter | $10\pm2$ mm | Unknown | ||
| length | $9\pm3$ mm | Unknown | ||
| Guiding Sheath | O.D. | $1.85\pm0.06$ mm | 1.83mm (distal)1.98mm (proximal) | Analysis 6 |
| I.D. | $0.98\pm0.06$ mm | 1.04mm (distal)1.27mm (proximal) | ||
| E.L. | $115\pm5$ cm$100\pm15$ cm | 123cm | ||
| Patient Contacting Materials | ||||
| Balloon | Silica gel | Silicone elastomer | Analysis 7 | |
| Outer tube | Pebax | Pebax | ||
| Braided tube | Polytetrafluoroethylene (PTFE) | Etched PTFE | ||
| Tip | Pebax and barium sulfate | Pebax and Barium sulfate | ||
| Guiding sheath tube | Pebax and barium sulfate | Pebax and Barium sulfate | ||
| Adhesive | Loctite UV Adhesive andDymax 204-CTH-T | Loctite UV Adhesive | ||
| Radiopaque Marker | Platinum Alloy | 90% Platinum/10% Iridium |
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| Method | EO Sterilized | EO Sterilized | Same |
|---|---|---|---|
| SAL | 10-6 | 10-6 | Same |
| Endotoxin Limit | 2.15 EU per device | 20 EU per device | Analysis 8 |
Analysis 1 - Product Code
The proposed device includes an additional product code QJP. The definition of QJP code is "To provide vascular access to the neurovasculature for interventional or diagnostic procedures." The additional product code does not raise new questions of safety and effectiveness.
Analysis 2 - Indications for Use
The indications for use of the proposed device are different from the predicate device. The proposed device does not claim the use of "The product is also indicated for use as a conduit for retrieval devices." Therefore, the difference of the indications for use does not raise new questions of safety and effectiveness.
Analysis 3 - Configuration / Components
There are differences in the set of components of the proposed device and the predicate. This however does not affect the intended use of the device.
Analysis 4 - Catheter specifications
The catheter dimensions for the outer diameter (OD), inner diameter (ID) and effective length (EL) are slightly different compared to the predicate device. However, the dimensional differences do not affect the intended use of the device.
Analysis 5 - Balloon specifications
The physician can control the size of the balloon expansion as necessary. Both devices are intended to provide temporary vascular occlusion during angiographic procedures.
Analysis 6 - Guiding sheath specifications
The guiding sheath dimensions for OD, ID and EL are slightly different compared to the predicate device. However, the dimensional difference does not affect the indications for use.
Analysis 7 - Patient-contacting materials
There are some differences in the patient-contacting materials of the proposed device versus the predicate device. However, the biocompatibility testing for the proposed device has been conducted per ISO 10993 standards. Therefore, the differences do not raise new questions of safety and effectiveness.
Analysis 8-Endotoxin Limit
The proposed device bacterial endotoxin level is below the level of 2.15 EU/device, and the predicate device bacterial endotoxin level is below the level of 20 EU/device. The proposed device has more stringent acceptance criteria for endotoxin levels, and the test results meet the requirements. Therefore, the differences do not raise new questions of safety and effectiveness.
-
- Non-Clinical Testing Summary [807.92(b)]
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Non-clinical tests were conducted to verify that the proposed device met all design specifications and is Substantially Equivalent (SE) to the predicate device. The test results demonstrate that the proposed device complies with the following standards:
-
ISO 10993-3:2014 "Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity'
-
ISO 10993-4:2017 "Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood"
-
ISO 10993-5:2009 "Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity"
-
ISO 10993-7:2008 "Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals."
- A ISO 10993-10:2010 "Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization"
-
ISO 10993-11:2017 "Biological evaluation of medical devices - Part 11: Tests for systemic toxicity"
-
ASTM F88/F88M-15 "Standard Test Method for Seal Strength of Flexible Barrier Materials"
-
ASTM F1929-15 "Standard Test Method for Detecting Seal Leaks in Porous Medical Package bv Dve Penetration"
- ASTM F1886 / F1886M-16 "Standard Test Method for Determining Integrity of Seals for Flexible > Packaging by Visual Inspection'
-
ASTM F756-17 "Standard Practice for Assessment of Hemolytic Properties of Materials"
- USP <151> Pyrogen Test A
-
USP <85> Bacterial Endotoxins Test
-
ISO 594-1: 1986 "Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements'
-
ISO 594-2: 1998 "Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings"
The results of verification and validation testing conducted on the Balloon Guiding Catheter demonstrate that it performs as designed, is suitable for its intended use and is substantially equivalent to the predicate device. A summary of the tests performed is provided in the table below:
| Test | Test Summary | Conclusion |
|---|---|---|
| Dimensional verification | Verify dimensions using specified measurement tools. Record measurements. | Size verification met acceptance criteria. |
| Radiopacity | The radiopaque marker on the catheter tip should be visible under X - ray. | The radiopaque marker on the catheter tip is visible under X - ray. |
| Torque testing | Rotate the catheter in the vascular model to demonstrate that the catheter is capable of rotation without failure. | The catheter body is not damaged and bent. |
| Balloon compliance | Expand the balloon with varying volumes of expansion liquid and measure the balloon size changes. | Compliant. |
| Balloon expansion and contraction time | Expand the balloon to the maximum volume, then pull the expansion liquid out, and record the time for expansion and contraction. | Balloon expansion and contraction times met acceptance criteria. |
| Balloon fatigue test | Repeat expanding and contracting theballoon 20 times to test for balloon leakageor damage. | The balloon is not leaking ordamaged |
| Balloon volume limit | Inject 2.5 times the limit volume of theexpansion agent into the balloon anddetermine if the balloon is damaged. | The balloon is not leaking ordamaged. |
| Peak tensile force | Use a tensile test machine to apply a tensileload to the sample and determine whether themaximum tensile force meets theacceptance Criteria. | Peak tensile force met acceptancecriteria. |
| Catheter bond strength | Use a tensile test machine to apply a tensileload to the bond point and determine if themaximum tensile force meets theacceptance criteria. | Catheterbondstrengthmetacceptance criteria. |
| Compatibility test | Simulated use testing with compatibledevices in a vascular model was performed. | The device can be used asintended. |
| Anti-collapse test | Suction the balloon with maximum suctionforce to test for increased friction or lumencollapse. | Compatible devices do notexperience increased blockingduring push and retracement, andthe catheter did not collapse. |
| Burst pressure | Burst pressure tests were performed atpressures greater than the manual syringeinjection pressures. | Burst pressure met acceptancecriteria. |
| Kink resistance | The proposed device was evaluated per FDAguidance Non-Clinical Engineering Tests andRecommended Labeling for IntravascularStents and Associated Delivery Systems,section IV, C.9 | Kink resistance met acceptancecriteria. |
| Air leakage | The proposed device was evaluated per ISO10555-1 to demonstrate that the productmeets the hub aspiration air leakagerequirements. | No air leakage |
| Liquid leakage | The proposed device was evaluated per ISO10555-1. To demonstrate that the devicemeets the liquid leakage under pressurerequirements. | No liquid leakage |
| Particulate testing | After simulating the use with compatibledevices, determine the quantity and size ofthe particles generated. | The number and size of theparticles were similar to that ofthe comparator device. |
| Connector performance | The proposed device was evaluated per ISO594-1 and 594-2 to demonstrate that theproduct meets the requirements for smallbore connectors. | Connector performance metacceptance criteria. |
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Biocompatibility
The device is categorized as Externally Communicating Device, Circulating Blood, Limited Contact (< 24 hours), per ISO 10993-1, the following testing was conducted:
{10}------------------------------------------------
| Test | Reference Standard | Test Summary | Conclusion |
|---|---|---|---|
| Cytotoxicity | Tested in accordance with ISO10993-5:2009, BiologicalEvaluation of Medical Devices– Part 5: Tests for in vitrotoxicity | Verify the viability, if viability isreduced to < 70% of the blank, ithas a cytotoxic potential. | Non-cytotoxic |
| Irritation | Tested in accordance with ISO10993-10:2010, BiologicalEvaluation of Medical DevicesPart 10: Tests for Irritation andSkin Sensitization | Study animals tested with thesubject device were observed fordermal sensitization. | No irritation |
| Sensitization | Tested in accordance with ISO10993-10,BiologicalEvaluation of Medical Devices- Part 10 Tests for Irritation andSkin Sensitization | Study animals tested with thesubject device were observed fordermal sensitization. | No sensitization |
| Systemic Toxicity | Tested in accordance with ISO10993-11:2017, BiologicalEvaluation of MedicalDevices- Part 11: Tests for SystemicToxicity | Study animals tested with thesubject device were observedfor abnormal clinical signsindicative of toxicity during the72-hour test period. | No systemic toxicity |
| Hemolysis | Tested in accordance withASTM F756-17, StandardPractice for Assessmentof Hemolytic Properties ofMaterials | The difference between thehemolytic indexes of the subjectdevice and the negative controlwas evaluated. | Non-hemolytic |
| MaterialMediatedPyrogenicity | Tested in accordance with ISO10993-11:2017, BiologicalEvaluation of Medical Devices -Part 11: Tests for SystemicToxicity and USP 42 <151>Pyrogen Test | Study animals were observed fortemperature rise. | Nonpyrogenic |
| In VivoThromboresistance | Tested in accordance with ISO10993-4:2017,BiologicalEvaluation of Medical Devices- Part 4: Selection of Tests forInteractions with Blood | Study animals with subject devicewere observed for thrombogenicpotentials and test resultsdemonstrated similarthromboresistance characteristicswith the control device. | Meet thepredetermined acceptance criteria,the test score is 0, i.e.,No thrombosis. |
| ComplementActivation | Tested in accordance with ISO10993-4, Biological Evaluationof Medical Devices – Part4:2017: Selection of Tests forInteractions with Blood, SC5b-9 Complement Activation | Comparison of the subject deviceSC5b-9 value to the predicatedevice for all exposure times wasperformed. | No statisticaldifference from thepredicate device |
| PartialThromboplastinTime | Tested in accordance with ISO10993-4:2017, BiologicalEvaluation of Medical Devices– Part 4: Selection of Tests forInteractions with Blood, andASTM F2382-2018, StandardTest Method for Assessment ofIntravascular Medical DeviceMaterials on PartialThromboplastin Time | The clotting time was observedfor both the subject device and thepredicate. | Nodifferencefrompredicate device |
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510(k) Summary
Sterilization and Shelf Life
The Balloon Guiding Catheter sterilization process using Ethylene Oxide (EO) has been validated in accordance with ISO 11135-1:2014 to achieve a sterility assurance level (SAL) of 106. 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 2 year shelf-life.
-
- Animal Testing
No animal studies were required to demonstrate substantial equivalence.
- Animal Testing
-
- Clinical Test Conclusion
No clinical studies were required to demonstrate substantial equivalence.
- Clinical Test Conclusion
-
- Conclusion
Shanghai Heartcare Medical Technology Co. Ltd. concludes through a review of the benchtop assessments, the comparison of the device classifications for use, technological characteristics, sterility, and biocompatibility testing that the Balloon Guiding Catheter is substantially equivalent to the predicate device.
- Conclusion
§ 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).