(194 days)
The ArteriA Occlusion Balloon is indicated for use as an intravascular occluding catheter with an inflatable balloon tip that is used for temporary occlusion of vessels. The technique of temporary occlusion is useful in selectively stopping or controlling blood flow. The ArteriA Occlusion Balloon may be used in the peripheral and neuro-vasculature where temporary occlusion is desired during endovascular procedures.
The ArteriA Occlusion Balloon is a single lumen, intravascular catheter with a compliant balloon at the distal end. An adapter at the proximal end of the shaft accesses the lumen. The catheter is constructed of stainless steel and a composite device designed to access the vessel. The proximal end of the catheter is fitted with an adapter. This adapter connects to the balloon inflation lumen and a fitting for attachment of a standard inflation syringe. The ArteriA Occlusion Catheter is supplied sterile and for single use.
Here's a breakdown of the acceptance criteria and study information for the ArteriA Occlusion Balloon, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Standard | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-1, Biological Evaluation of Medical Devices (External communicating, blood contact, short duration <24 hrs.) | Test results confirmed biocompatibility. |
| Sterilization | ISO 11135, Validation and routine control of ethylene oxide sterilization (Sterility Assurance Level (SAL) of 10⁻⁶) | Validated to a SAL of 10⁻⁶. |
| Performance (Dimensional) | ISO 10555, Sterile, single use intravascular catheters, Parts 1 and 4 | Meets or exceeds requirements. |
| Performance (Balloon Compliance & Integrity) | ISO 10555, Sterile, single use intravascular catheters, Parts 1 and 4 | Meets or exceeds requirements. |
| Performance (Catheter Tensile Strength) | ISO 10555, Sterile, single use intravascular catheters, Parts 1 and 4 | Meets or exceeds requirements. |
| Performance (Torque Strength) | ISO 10555, Sterile, single use intravascular catheters, Parts 1 and 4 | Meets or exceeds requirements. |
| Performance (Flexibility) | ISO 10555, Sterile, single use intravascular catheters, Parts 1 and 4 | Meets or exceeds requirements. |
| Performance (Trackability) | ISO 10555, Sterile, single use intravascular catheters, Parts 1 and 4 | Meets or exceeds requirements. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set for any of the performance studies. It also does not provide information on data provenance (e.g., country of origin, retrospective or prospective). The studies described are engineering/laboratory tests, not clinical studies with human subjects.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the studies described are laboratory and engineering performance tests of the device itself, not evaluations of a diagnostic algorithm where expert ground truth would be established.
4. Adjudication Method for the Test Set
This information is not applicable for the reasons stated above. Adjudication methods are typically relevant for clinical studies or studies involving human interpretation of data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not reported. The information provided describes device performance and safety testing, not a study evaluating human reader performance with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This information is not applicable. The device described is a physical medical device (an occlusion balloon catheter), not an algorithm or AI software. Therefore, there is no "algorithm only" performance to report.
7. The Type of Ground Truth Used
The "ground truth" for the tests described are the specified requirements and benchmarks within the referenced ISO standards (ISO 10993-1, ISO 11135, and ISO 10555 Parts 1 and 4). For example, a "ground truth" for tensile strength would be a minimum force required before failure, as defined by the standard.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" in the context of this device's testing, as it is a physical medical device, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated above.
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OCT 2 8 2002
Image /page/0/Picture/1 description: The image shows the logo for Arteria. The logo consists of a circular graphic to the left of the company name. The graphic is a circle with three dark sections and a Y-shaped pattern of small circles in the center. The company name "ArteriA" is written in a serif font to the right of the graphic, with a small "TM" symbol next to the "A".
510(k) Summary ArteriA Occlusion Balloon
K021210
Date Prepared: August 14, 2002
This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
Submitter
ArteriA Medical Science, Inc. The Presidio, Building 220, Suite 120 San Francisco, CA 94129
Company Contact
Alan Hinton, Quality Assurance
Device Name
| Trade Name: | ArteriA Occlusion Balloon |
|---|---|
| Common Name: | Balloon Occlusion Catheter |
Classification Name: Catheter, Intravascular Occluding Temporary
Predicate Devices
MicroTherapeutics, Inc., Equinox 104 Occlusion Balloon Catheter, K990487
MicroTherapeutics, Inc., HyperForm™ Occlusion Balloon Catheter, K011656
Description of Device
The ArteriA Occlusion Balloon is a single lumen, intravascular catheter with a compliant balloon at the distal end. An adapter at the proximal end of the shaft accesses the lumen. The catheter is constructed of stainless steel and a composite device designed to access the vessel. The proximal end of the catheter is fitted with an adapter. This adapter connects to the balloon inflation lumen and a fitting for attachment of a standard inflation syringe. The ArteriA Occlusion Catheter is supplied sterile and for single use.
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Intended Use
The ArteriA Occlusion Balloon Catheter is indicated for use as an intravascular occluding catheter with an inflatable balloon tip that is used for temporary occlusion of vessels. This technique of temporary occlusion is useful in selectively stopping or controlling blood flow. The ArteriA Occlusion Balloon may be used in the peripheral and neuro-vasculature where temporary occlusion is desired during endovascular procedures.
Tests Submitted
Biocompatibility of the ArteriA Occlusion Balloon was verified in accordance with ISO 10993-1, Biological Evaluation of Medical Devices. Test results confirmed biocompatibility of the ArteriA Occlusion Balloon when tested as an external communicating, blood contact, short duration (<24 hrs.) device.
The sterilization process was validated to a Sterility Assurance Level (SAL) of 106 in accordance with ISO 11135, Validation and routine control of ethylene oxide sterilization.
Performance testing of the ArteriA Occlusion Balloon was conducted in accordance with ISO 10555, Sterile, single use intravascular catheters, Parts 1 and 4. Tests included dimensional verification, balloon compliance and integrity, catheter tensile strength, torque strength, flexibility and trackability. Test results demonstrate that the device meets or exceeds the requirements of these standards.
Comparison of Technological Characteristics
The basic technologies, design and function of ArteriA Medical Science, Inc.'s ArteriA Occlusion Balloon are substantially equivalent in design, materials of construction, function, and intended use to the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text reading "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes, possibly representing people or services provided by the department. The logo is in black and white.
9200 Corporate Boulevard Rockville MD 20850
OCT 2 8 2002
ArteriA Medical Science, Inc. c/o Mr. Alan C. Hinton The Presidio, Building 220 Suite 120 San Francisco, CA 94129
Re: K021210
ArteriA Occlusion Balloon Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular clamp Regulatory Class: Class II (two) Product Code: MJN Dated: August 14, 2002 Received: August 16, 2002
Dear Mr. Hinton:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 – Mr. Alan C. Hinton
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation cntitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Kala Tula
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number :
Device Name : ArteriA Occlusion Balloon
Indications for Use: . .
The ArteriA Occlusion Balloon is indicated for use as an intravascular occluding catheter with an inflatable balloon tip that is used for temporary occlusion of vessels. The technique of temporary occlusion is useful in selectively stopping or controlling blood flow. The ArteriA Occlusion Balloon may be used in the peripheral and neuro-vasculature where temporary occlusion is desired during endovascular procedures.
(PLEASE DO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) (Optional Format 1-2-96)
OR
Over-the-Counter
Division of Cardiovascular & Respiratory Devices
510(k) Number K021210
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).