(113 days)
Not Found
No
The device description and intended use are purely mechanical, describing a balloon catheter for angioplasty. There is no mention of any software, algorithms, or data processing that would suggest AI/ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are explicitly marked as "Not Found".
Yes
The device is used for balloon dilatation of arteries, which is a medical procedure to treat arterial narrowing or blockages, directly addressing a health condition.
No
The device description indicates its purpose is balloon dilatation, which is a therapeutic intervention, not a diagnostic one. While it uses fluoroscopy for guidance, its primary function is to treat arterial blockage, not to identify or characterize a condition.
No
The device description clearly details a physical catheter with a balloon, hub, and platinum iridium bands, indicating it is a hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states this device is a balloon dilatation catheter used for a procedure (angioplasty) within the arteries. It is used in vivo (inside the body) to physically open narrowed blood vessels.
- Lack of Sample Testing: There is no mention of this device being used to test any biological samples.
The device is a therapeutic medical device used for a surgical procedure, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
Balloon dilatation of the femoral, popliteal and infra-popliteal arteries. These catheters are not designed to be used in the coronary arteries.
Product codes
LIT
Device Description
A family of semi-compliant coaxial design catheters in various sizes. Each catheter has a balloon mounted on its distal tip. A hub/"Y" connector consists of a through lumen, allowing the catheter to track over a guidewire, and a balloon port used to inflate the balloon. To locate the balloon under fluoroscopy platinum iridium bands are provided at the shoulders of the balloon for all sizes. The proximal end of the catheter is provided with a transparent hub which allows easy observation of air bubbles. The hub is designed to facilitate easy removal of air bubbles during the preparation of the balloon.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopy
Anatomical Site
femoral, popliteal and infra-popliteal arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Performance testing and compliance with recognized standards have established substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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).
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K072947 Page 1 of 1
Premarket Notification - ClearStream Technologies PTA Catheters
510(k) SUMMARY
This 510(k) Summary is being submitted in accordance with the requirements of 21 CFR 8807.92.
Submitter Information:
ClearStream Technologies Moyne Upper, Enniscorthy,Co. Wexford. Ireland
Date Summary Prepared: January 3, 2008
Contact Persons:
lan P Gordon Senior Vice President Emergo Group, Inc. 1705 S Capital of Texas Hwy Suite 500 Austin TX 78746 Fax 512-327-9998
Device Name:
Trade Name(s): Savvy Long and Sleek Peripheral Transluminal Angioplasty (PTA) Catheters Classification Name: Percutaneous catheter Classification Regulation: 21 CFR 870.1250 Panel: Cardiovascular Product Code: LIT
Predicate Device Information:
Device Name: Submarine Plus Percutaneous Transluminal Angioplasty (PTA) Catheters Manufacturer: Invatec Innovative Technologies Reference: K042537
Device Description:
A family of semi-compliant coaxial design catheters in various sizes. Each catheter has a balloon mounted on its distal tip. A hub/"Y" connector consists of a through lumen, allowing the catheter to track over a guidewire, and a balloon port used to inflate the balloon. To locate the balloon under fluoroscopy platinum iridium bands are provided at the shoulders of the balloon for all sizes. The proximal end of the catheter is provided with a transparent hub which allows easy observation of air bubbles. The hub is designed to facilitate easy removal of air bubbles during the preparation of the balloon.
Intended Use:
Balloon dilatation of the femoral, popliteal and infra-popliteal arteries. These catheters are not designed to be used in the coronary arteries.
Comparison to Predicate Device:
This device is equivalent to the predicate device in intended use, design characteristics, and general physical characteristics.
Testing and Conclusions:
Performance testing and compliance with recognized standards have established substantial equivalence.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
FEB - 8 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Clearstream Technologies, Ltd. c/o Mr. Ian Gordon Emergo Group, Inc. 1705 S. Capital of Texas Hwy, Suite 500 Austin, TX 78746
Re: K072947
Trade/Device Name: Savvy Long and Sleek PTA Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: LIT Dated: January 8, 2008 Received: January 10, 2008
Dear Mr. Gordon:
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.
2
Page 2 - Mr. Ian Gordon
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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Dma R. bochner
ABram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K072947
Device Name: ClearStream Technologies PTA Catheters
Indications for Use:
Balloon dilatation of the femoral, popliteal and infra-popliteal arteries. These catheters are not designed to be used in the coronary arteries.
Prescription Use XX (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
suma D. Valmes
(Division Sich-Off) Division or Cardiovascular Devices
710(k) Number_K072947