(98 days)
The OPTIMUS 0.035" PTA Balloon Dilation Catheter is intended to dilate stenoses in the Illiac, Femoral, Popliteal and Renal arteries.
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 markerbands 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.
The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of diagnostic performance (e.g., sensitivity, specificity, accuracy). Instead, it's a 510(k) summary for a medical device (OPTIMUS 0.035" PTA Balloon Dilatation Catheter) seeking "substantial equivalence" to a predicate device.
Here's an analysis of the provided information in relation to your request:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The document does not list acceptance criteria in terms of specific performance metrics like sensitivity, specificity, or any quantitative targets that a diagnostic device would typically have.
- Reported Device Performance: The document states: "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." It also mentions "The device has been tested according to ISO 10993 Part 1 and has been determined to be biocompatible."
- This indicates performance was evaluated against the predicate device and in terms of biocompatibility, but no specific numerical performance values are given.
- The "performance data" section refers to non-clinical design verification/validation tests, which typically involve engineering tests (e.g., burst pressure, fatigue, trackability, etc.) to ensure the device functions as intended and safely, rather than clinical efficacy/diagnostic performance.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not provide details on sample size for any test set or the provenance of data. The "tests and analyses" mentioned are non-clinical, implying benchtop or in-vitro tests, not patient studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This information is not applicable and not provided in this document. Ground truth, experts, and their qualifications are relevant for studies determining accuracy or diagnostic performance, which is not the type of evaluation described here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable and not provided. Adjudication methods are used in clinical trials or diagnostic studies to resolve discrepancies in expert assessment, which is not the subject of this 510(k) summary.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- An MRMC comparative effectiveness study was not done and is not mentioned. This type of study is relevant for AI-assisted diagnostic tools, which this device is not.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- A standalone performance assessment (algorithm only) was not done and is not mentioned. This is also relevant for AI/software devices. The OPTIMUS is a physical medical catheter.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Ground truth as typically understood for diagnostic device evaluation (e.g., expert consensus, pathology) is not applicable and not discussed for this device. The "ground truth" for a catheter would be its physical specifications and functional performance in a simulated environment.
8. The sample size for the training set
- A "training set" is typically associated with machine learning or AI models. This document does not mention a training set as the device is a physical catheter, not an AI or software algorithm.
9. How the ground truth for the training set was established
- This question is not applicable as there is no mention of a training set or ground truth for such a set.
Summary:
The provided document describes a 510(k) Pre-market Notification for a medical device, the OPTIMUS 0.035" PTA Balloon Dilatation Catheter. The primary objective of a 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to prove specific diagnostic performance against quantitative acceptance criteria in a clinical setting.
The "performance data" mentioned refers to non-clinical design verification/validation tests (e.g., biocompatibility testing per ISO 10993 Part 1), which verify that the device meets its design specifications and safety requirements, and that it performs comparably to the predicate device in terms of engineering and functional characteristics. It does not involve patient data, expert interpretations, or diagnostic performance metrics like sensitivity or specificity.
{0}------------------------------------------------
USCI Ireland Universal Sciences Catheters & Instruments
2.5 510(k) Summary
OPTIMUS 0.035" PTA Balloon Dilatation Catheter
This 510(k) Summary is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
1. General Information
| Submitter: | USCI IrelandIDA Business Park,Ballinasloe,Co. Galway,Ireland | NOV 0 9 2007 |
|---|---|---|
| Telephone Number: | 011 353 909 646300 | |
| Fax Number: | 011 353 909 646330 | |
| Contact Person: | Denise Kennedy | |
| Summary Preparation Date: | 1st August 2007 | |
| 2. | Device Information | |
| Device Name: | OPTIMUS 0.035" PTA Balloon DilatationCatheter | |
| Common Name: | PTA Balloon Dilatation Catheter | |
| Classification Name: | Catheter, Angioplasty, Peripheral, Transluminal(21 CFR 870.1250, Product Code: DQY) | |
| 3. | Predicate Devices | |
| Device Name: | Cordis OPTA PRO PTA Catheter |
K032737 510(k) Clearance Number:
This Premarket Notification (510(k) submission) aims to demonstrate "substantial equivalence (SE)" of the USCI OPTIMUS 0.035" PTA Balloon Dilatation Catheter through comparison with the "predicate device" - Cordis OPTA PRO. The Substantial Equivalence discussion is documented in section 2.12. Substantial equivalence (SE) is demonstrated within the "intended use" of the OPTIMUS device. Where SE is not directly demonstrated from the perspective of technology and performance, design verification testing provides evidence of the safety and effectiveness of the OPTIMUS device. The design verification testing is detailed in section 2.18 of this submission - Performance Testing.
4. Device Description
USCI Ireland IDA Business Park, Ballinasloe, Co Galway, Ireland VAT: 9989802K
CONFIDENTIAL
K072156 p. L of 2
{1}------------------------------------------------
USCI Ireland Universal Sciences Catheters & Instruments
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 markerbands 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.
5. Indications for Use
The OPTIMUS 0.035" PTA Balloon Dilation Catheter is intended to dilate stenoses in the Iliac, Femoral, Popliteal and Renal arteries.
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 has been determined to be biocompatible.
:
USCI Ireland IDA Business Park, Ballinasloe, Co Galway, Ireland VAT: 9989802K
. . . . .
{2}------------------------------------------------
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 0 9 2002
USCI Ireland c/o Ms. Denise Kennedy Senior DA & RA Engineer IDA Business Park Ballinasloe, Co Galway, Ireland
Re: K072156 Optimus 0.035" PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: II (Two) Product Code: DQY Dated: October 09, 2007 Received: October 10, 2007
Dear Ms. Kennedy:
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. Denise Kennedy
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,
Durna R. Lochner
( J 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: K072156
Device Name: OPTIMUS 0.035" PTA Balloon Dilatation Catheter
Indications for Use:
The OPTIMUS 0.035" PTA Balloon Dilation Catheter is intended to dilate stenoses in the Illiac, Femoral, Popliteal and Renal arteries.
Prescription Use 区 (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)
vuna R. Vaclues
(Division Sig - ିମ୍ (Division Sign only
Page 1 of 1
510(K) Number Ko 77 150
CONFIDENTIAL
Page 3 of 107
§ 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).