(53 days)
No
The description focuses on the mechanical aspects of a balloon catheter and does not mention any AI/ML components or functionalities.
Yes
The device is intended to treat a medical condition (stenoses in arteries) by directly performing a physical action (dilating) on the body.
No
The device is a medical catheter used to dilate stenoses in arteries, which is a therapeutic function, not a diagnostic one.
No
The device description clearly describes a physical catheter with lumens, a balloon, and radiopaque marker bands, 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 is to "dilate stenoses in the Illiac, Femoral, Popliteal and Renal arteries." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The description details a physical catheter with a balloon for mechanical dilation. It does not describe a device used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any process related to in vitro testing.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is used inside the body for a therapeutic intervention.
N/A
Intended Use / Indications for Use
The OPTIMUS 0.035" PTA Balloon Dilatation Catheter is intended to dilate stenoses in the Iliac, Femoral, Popliteal and Renal arteries.
Product codes
DQY
Device Description
The OPTIMUS 0.035" PTA Balloon Dilatation Catheter is a two lumen catheter with a distal inflatable balloon. One lumen is used for inflation of the balloon with contrast medium; the other lumen permits the use of a guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. Two radiopaque marker bands indicate the dilatating section of the balloon and aid in the balloon placement. The marker bands also indicate the stated nominal length of the balloon. The catheter tip is designed to ease entry into the indicated arteries and to facilitate the crossing of tight stenoses.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Iliac, Femoral, Popliteal and Renal 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)
Substantial equivalence of the OPTIMUS 0.035" PTA Balloon Dilatation Catheter to the predicate device has been demonstrated through data collected from non-clinical design verification/ validation tests and analyses. The device has been tested according to ISO 10993 Part 1 and was determined to be biocompatible.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
OPTIMUS 0.035" PTA Balloon Dilatation Catheter K072156
Reference Device(s)
Cordis OPTA PRO PTA Catheter K032737, Invatec SAILOR PLUS PTA Catheter K042538
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
K082646 page 1 of 3
USCI Ireland NOV - 3 2008 Universal Sciences Catheters & Instruments
2.5 510(k) Summary
OPTIMUS 0.035" PTA Balloon Dilatation Catheter
This Special 510(k) Summary is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
2.5.1
General Information
Submitter:
Telephone Number:
Fax Number:
Contact Person:
Summary Preparation Date:
2.5.2 Device Information
Device Name:
Common Name:
Classification Name:
USCI Ireland IDA Business Park, Ballinasloe, Co. Galway, Ireland
011 353 909 646300
011 353 909 646330
Ailish O'Reilly
September 4th 2008
OPTIMUS 0.035" PTA Balloon Dilatation Catheter
PTA Balloon Dilatation Catheter
Catheter, Angioplasty, Peripheral, Transluminal (21 CFR 870.1250, Product Code: DQY)
2.5.3 Predicate Devices
Device Name:
510(k) Clearance Number:
Device Name:
510(k) Clearance Number:
Device Name:
510(k) Clearance Number:
OPTIMUS 0.035" PTA Balloon Dilatation Catheter
Cordis OPTA PRO PTA Catheter
Invatec SAILOR PLUS PTA Catheter
USC! Ireland IDA Business Park, Ballinasloe, Co Galway, Ireland VAT: 9989802K
CONFIDENTIAL
Page 4 of 97
1
USCI) USCI Ireland Universal Sciences Catheters & Instruments
2.5.4 Device Description
The OPTIMUS 0.035" PTA Balloon Dilatation Catheter is a two lumen catheter with a distal inflatable balloon. One lumen is used for inflation of the balloon with contrast medium; the other lumen permits the use of a guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. Two radiopaque marker bands indicate the dilatating section of the balloon and aid in the balloon placement. The marker bands also indicate the stated nominal length of the balloon. The catheter tip is designed to ease entry into the indicated arteries and to facilitate the crossing of tight stenoses.
2.5.5 Indications for Use
The OPTIMUS 0.035" PTA Balloon Dilatation Catheter is intended to dilate stenoses in the Iliac, Femoral, Popliteal and Renal arteries.
2.5.6 Performance Data
Substantial equivalence of the OPTIMUS 0.035" PTA Balloon Dilatation Catheter to the predicate device has been demonstrated through data collected from non-clinical design verification/ validation tests and analyses. The device has been tested according to ISO 10993 Part 1 and was determined to be biocompatible.
USCI Ireland IDA Business Park, Ballinasloe, Co Galway, Ireland VAT: 9989802K
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the logo. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 3 2008
Complete Comments of the Comments of Children and Children Comments of Children of Children
USCI Ireland c/o Ms. Ailish O'Reilly IDA Business Park Ballinasloc Co. Galway Ireland
Re: K082646
OPTIMUS 0.035" PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (2) Product Code: DQY Dated: October 2, 2008 Received: October 7, 2008
Dear Ms. O'Reilly:
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.
3
Page 2 - Ms. Ailish O'Reilly
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 prodicate device results in a classification for your device and thus, permits your device to proceed to the market.
പ്രത്തേത്തിന് വിക്കുന്നതിനു പ്രാമ്പ്യക്ഷേത്രിൽ തിരിച്ച് നിന്നും എന്ന ക്ഷേത്രത്തിനായ വേണ്ടി വിശ്വീനിക്കുന്നതിന്റെ എക്കുകയുടെ
If you desire spccific 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 yours,
Duna R. Holmes
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
2.4 Indications for Use
510(k) Number: K082646
Device Name: OPTIMUS 0.035" PTA Balloon Dilatation Catheter
ച്ചത്തിന് അവലംബം പ്രസിഡ് എന്നിവ് എന്നിവിടങ്ങി നിന്നും പ്രകൃത്തിന്റെ സമ്പേഷ് ക്രിക്കുന്നതാണ് അവലംബം സ്ഥിച്ചിരിക്കുന്നത്.
Indications for Use:
The OPTIMUS 0.035" PTA Balloon Dilatation Catheter is intended to dilate stenoses in the Illiac, Femoral, Popliteal and Renal arteries.
Prescription Use & (Part 21 CFR 801 Subpart D)
And/ Or
Over-The- Counter Use [ (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Duna R. Lo liner
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number_≤08264
CONFIDENTIAL
Page 3 of 97