(87 days)
Not Found
No
The device description focuses on the mechanical components and materials of a balloon catheter, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is a balloon dilation catheter used for angioplasty, which is a medical procedure to widen narrowed or obstructed arteries, thereby treating a medical condition.
No
The device description clearly states its purpose as "balloon dilatation...for angioplasty," and its function is to inflate and deflate a balloon for therapeutic intervention, not to diagnose a condition. The use of "radiopaque bands... to locate the balloon under fluoroscopy" is for guiding the therapeutic procedure, not for diagnosis.
No
The device description clearly details physical components such as a stainless steel guidewire shaft, polymer bodybond material, copolymer inflation lumen, balloon material, and radiopaque bands, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Balloon dilatation of the femoral, popliteal and infra-popliteal arteries." This describes a therapeutic procedure performed directly on the patient's body.
- Device Description: The description details a physical catheter with a balloon designed for mechanical dilation within blood vessels.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
This device is a therapeutic medical device used for interventional procedures.
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, DQY
Device Description
The ReeKross family of over the wire PTA catheters are a balloon dilation catheter for angioplasty. They consist of a stainless steel guidewire shaft that extends from the proximal hub to the distal tip of the catheter. This stainless steel shaft has a spiral cut positioned at its distal end. The spiral cut is laser cut and passivated following completion. A polymer bodybond material is used to seal the spiral cut and ensure that the contrast solution remains in the inflation lumen only and does not leak into the guidewire lumen. This bodybond material is fused onto the outside diameter of the stainless steel shaft. A copolymer inflation lumen extends from the proximal hub of the catheter to the proximal shoulder of the balloon. The lumen of the shaft is used for the purpose of inflating and deflating the balloon. This outer is thermally fused to the balloon's proximal shoulder.
The balloon material is a Nylon/Pebax blend. Low Profile Platinum Radiopaque bands are used to locate the balloon under fluoroscopy. These bands are swaged onto the bodybond material sealing the spiral cut section of the guidewire lumen.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral, popliteal and infra popliteal arteries
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)
Performance testing and compliance with recognized standards have established substantial equivalence with regard to safety and effectiveness.
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).
0
Premarket Notification - ClearStream Technologies PTA Catheters
MAR = 2 2009
510(k) SUMMARY
11:13:13
The summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
Submitter Information: ClearStream Technologies Ltd, Moyne Upper, Enniscorthy, Co Wexford, Ireland. Phone: 00 353 53 9237111 Fax: 00 353 53 9237100
Date Summary Prepared: March 19, 2008
Contact Person: Fiona Ní Mhullain
Device Name: Trade Name(s): ReeKross™, ReeKross™14 and ReeKross™18 over the wire 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: Savvy Long
Manufacturer: ClearStream Technologies Ltd
Reference: K072947
Device Description:
CONFIDEN
1
Premarket Notification - ClearStream Technologies PTA Catheters
The ReeKross family of over the wire PTA catheters are a balloon dilation catheter for angioplasty. They consist of a stainless steel guidewire shaft that extends from the proximal hub to the distal tip of the catheter. This stainless steel shaft has a spiral cut positioned at its distal end. The spiral cut is laser cut and passivated following completion. A polymer bodybond material is used to seal the spiral cut and ensure that the contrast solution remains in the inflation lumen only and does not leak into the guidewire lumen. This bodybond material is fused onto the outside diameter of the stainless steel shaft. A copolymer inflation lumen extends from the proximal hub of the catheter to the proximal shoulder of the balloon. The lumen of the shaft is used for the purpose of inflating and deflating the balloon. This outer is thermally fused to the balloon's proximal shoulder.
The balloon material is a Nylon/Pebax blend. Low Profile Platinum Radiopaque bands are used to locate the balloon under fluoroscopy. These bands are swaged onto the bodybond material sealing the spiral cut section of the guidewire lumen.
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 Conclusion:
Performance testing and compliance with recognized standards have established substantial equivalence with regard to safety and effectiveness.
2
Page 3 - Mr. Harry van Vugt
(Please include 510(k) number here: K083596)
| HFZ # | Last Name | Date | HFZ # | Last Name | Date | HFZ # | Last Name | Date |
|---|---|---|---|---|---|---|---|---|
| 450 | Courtney | 22209 | ||||||
| 450 | Comage | 2/2/01 | ||||||
| 2-450 | Vchuller | 7/27/09 |
HFZ-401 DMC cc: HFZ-404 510(k) Staff HFZ-450 Division D.O.
Prepared by:TDCourtney:myb:02/27/09
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services, USA. The seal features a stylized eagle with outstretched wings, symbolizing the department's mission to protect the health of all Americans. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ClearStream Technologies. Inc. c/o Mr. Robert A. van Boxtel KEMA Quality B.V. Utrechtseweg 310 Arnhem Netherlands NL-6812 AR
MAR - 2 2009
Re: K083596
Trade Name: Reekross OTW PTA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: February 19, 2009 Received: February 20, 2009
Dear Mr. van Boxtel:
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, Or to 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 deview 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 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
4
Page 2 - Mr. Robert van Boxtel
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 Biometrics' (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 vours.
una R. Vulin
Image /page/4/Picture/6 description: The image shows a handwritten signature or symbol. It appears to be a stylized combination of letters, possibly an 'S' and an 'm' or 'n', connected in a cursive style. The stroke begins with a curve, forms a loop, and ends with a downward stroke.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Premarket Notification - ClearStream Technologies PTA Catheters
Indications for Use
510(k) Number (if known):
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)
Duna R. de Lunes
Division Sign-Off) Division of Cardiovascular Devices
10(k) Number