(330 days)
Not Found
No
The summary describes a physical medical device (catheter with a balloon) and its mechanical and biocompatibility testing. There is no mention of software, algorithms, image processing for analysis, or any terms related to AI/ML.
No
The device is primarily intended to assist in the placement and guidance of other catheters, and its balloon feature provides temporary vascular occlusion during angiography, which is typically a diagnostic or interventional imaging procedure, not in itself a therapeutic action by this device.
No
The device is described as a catheter for guiding other intravascular catheters and for temporary vascular occlusion during angiography. Its function is interventional/procedural, not diagnostic.
No
The device description clearly describes a physical catheter with a balloon, radiopaque marker, and various material properties, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within the body) to assist in guiding catheters and providing temporary vascular occlusion. IVDs are used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The description details a physical catheter designed for insertion into the vascular system. This is consistent with an in vivo medical device, not an in vitro diagnostic test.
- Anatomical Site: The specified anatomical site is the neuro or peripheral vascular system, which is an in vivo location.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or providing diagnostic information based on laboratory testing.
Therefore, the Balloon Guiding Catheter is an in vivo medical device, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
QJP, DQY
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neuro or peripheral vascular system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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."
- 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 Pyrogen Test A
- USP 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"
Summary of the tests performed:
- Dimensional verification: Size verification met acceptance criteria.
- Radiopacity: The radiopaque marker on the catheter tip is visible under X - ray.
- Torque testing: The catheter body is not damaged and bent.
- Balloon compliance: Compliant.
- Balloon expansion and contraction time: Balloon expansion and contraction times met acceptance criteria.
- Balloon fatigue test: The balloon is not leaking or damaged
- Balloon volume limit: The balloon is not leaking or damaged.
- Peak tensile force: Peak tensile force met acceptance criteria.
- Catheter bond strength: Catheter bond strength met acceptance criteria.
- Compatibility test: The device can be used as intended.
- Anti-collapse test: Compatible devices do not experience increased blocking during push and retracement, and the catheter did not collapse.
- Burst pressure: Burst pressure met acceptance criteria.
- Kink resistance: Kink resistance met acceptance criteria.
- Air leakage: No air leakage
- Liquid leakage: No liquid leakage
- Particulate testing: The number and size of the particles were similar to that of the Comparator device.
- Connector performance: Connector performance met acceptance criteria.
Biocompatibility testing results:
- Cytotoxicity: Non-cytotoxic
- Irritation: No irritation
- Sensitization: No sensitization
- Systemic Toxicity: No systemic toxicity
- Hemolysis: Non-hemolytic
- Material Mediated Pyrogenicity: Nonpyrogenic
- In Vivo Thromboresistance: Meet the predetermined acceptance criteria, the test score is 0, i.e., No thrombosis.
- Complement Activation: No statistical difference from the predicate device
- Partial Thromboplastin Time: No difference from predicate device
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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
2
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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3
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 Device
Predicate Device | | Remark |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | K202916 | K122581 | |
| Device | Balloon Guiding Catheter | Modified Balloon Guide
Catheter | |
| 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 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 Modified Balloon Guide
Catheter is indicated for use in
facilitating the insertion and
guidance of an intravascular
catheter into a selected blood
vessel in the peripheral and
neuro vascular systems. The
balloon provides temporary
vascular occlusion during these
and other angiographic
procedures. The Balloon Guide
Catheter is also indicated for
use as a conduit for
Retrieval 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 | ||
|---|---|---|
6
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. | SM*BGC-S80: $2.6\pm0.5$ mm | ||
| SM*BGC-S95: $2.6\pm0.5$ mm | ||||
| SM*BGC-S+80: $3.0\pm0.5$ mm | ||||
| SM*BGC-S+95: $3.0\pm0.5$ mm | 2.7mm (8F) | Analysis 4 | ||
| I.D. | SM*BGC-S80: $1.98\pm0.06$ mm | |||
| SM*BGC-S95: $1.98\pm0.06$ mm | ||||
| SM*BGC-S+80: $2.25\pm0.06$ mm | ||||
| SM*BGC-S+95: $2.25\pm0.06$ mm | 2.1mm (6.4F) | |||
| E.L. | SM*BGC-S80: $80\pm5$ cm | |||
| SM*BGC-S95: $95\pm5$ cm | ||||
| SM*BGC-S+80: $80\pm5$ cm | ||||
| SM*BGC-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 and | |||
| Dymax 204-CTH-T | Loctite UV Adhesive | |||
| Radiopaque Marker | Platinum Alloy | 90% Platinum/10% Iridium |
7
| 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)]
8
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 Pyrogen Test A
-
USP 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 the | |
| balloon 20 times to test for balloon leakage | ||
| or damage. | The balloon is not leaking or | |
| damaged | ||
| Balloon volume limit | Inject 2.5 times the limit volume of the | |
| expansion agent into the balloon and | ||
| determine if the balloon is damaged. | The balloon is not leaking or | |
| damaged. | ||
| Peak tensile force | Use a tensile test machine to apply a tensile | |
| load to the sample and determine whether the | ||
| maximum tensile force meets the | ||
| acceptance Criteria. | Peak tensile force met acceptance | |
| criteria. | ||
| Catheter bond strength | Use a tensile test machine to apply a tensile | |
| load to the bond point and determine if the | ||
| maximum tensile force meets the | ||
| acceptance criteria. | Catheter | |
| bond | ||
| strength | ||
| met | ||
| acceptance criteria. | ||
| Compatibility test | Simulated use testing with compatible | |
| devices in a vascular model was performed. | The device can be used as | |
| intended. | ||
| Anti-collapse test | Suction the balloon with maximum suction | |
| force to test for increased friction or lumen | ||
| collapse. | Compatible devices do not | |
| experience increased blocking | ||
| during push and retracement, and | ||
| the catheter did not collapse. | ||
| Burst pressure | Burst pressure tests were performed at | |
| pressures greater than the manual syringe | ||
| injection pressures. | Burst pressure met acceptance | |
| criteria. | ||
| Kink resistance | The proposed device was evaluated per FDA | |
| guidance Non-Clinical Engineering Tests and | ||
| Recommended Labeling for Intravascular | ||
| Stents and Associated Delivery Systems, | ||
| section IV, C.9 | Kink resistance met acceptance | |
| criteria. | ||
| Air leakage | The proposed device was evaluated per ISO | |
| 10555-1 to demonstrate that the product | ||
| meets the hub aspiration air leakage | ||
| requirements. | No air leakage | |
| Liquid leakage | The proposed device was evaluated per ISO | |
| 10555-1. To demonstrate that the device | ||
| meets the liquid leakage under pressure | ||
| requirements. | No liquid leakage | |
| Particulate testing | After simulating the use with compatible | |
| devices, determine the quantity and size of | ||
| the particles generated. | The number and size of the | |
| particles were similar to that of | ||
| the comparator device. | ||
| Connector performance | The proposed device was evaluated per ISO | |
| 594-1 and 594-2 to demonstrate that the | ||
| product meets the requirements for small | ||
| bore connectors. | Connector performance met | |
| acceptance criteria. |
9
Biocompatibility
The device is categorized as Externally Communicating Device, Circulating Blood, Limited Contact (
Pyrogen Test | Study animals were observed for
temperature rise. | Nonpyrogenic |
| In Vivo
Thromboresistance | Tested in accordance with ISO
10993-4:2017,
Biological
Evaluation of Medical Devices
- Part 4: Selection of Tests for
Interactions with Blood | Study animals with subject device
were observed for thrombogenic
potentials and test results
demonstrated similar
thromboresistance characteristics
with the control device. | Meet the
predetermined acceptance criteria,
the test score is 0, i.e.,
No thrombosis. |
| Complement
Activation | Tested in accordance with ISO
10993-4, Biological Evaluation
of Medical Devices – Part
4:2017: Selection of Tests for
Interactions with Blood, SC5b-
9 Complement Activation | Comparison of the subject device
SC5b-9 value to the predicate
device for all exposure times was
performed. | No statistical
difference from the
predicate device |
| Partial
Thromboplastin
Time | Tested in accordance with ISO
10993-4:2017, Biological
Evaluation of Medical Devices
– Part 4: Selection of Tests for
Interactions with Blood, and
ASTM F2382-2018, Standard
Test Method for Assessment of
Intravascular Medical Device
Materials on Partial
Thromboplastin Time | The clotting time was observed
for both the subject device and the
predicate. | No
difference
from
predicate device |
11
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 . 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