(28 days)
The ELM PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and the renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.
The ELM is a coaxial PTA Balloon Dilatation 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 dilating section of the balloon and aid in the balloon placement. The marker bands also indicate the nominal length of the balloon. The catheter tip is designed to ease entry into the peripheral arteries and to facilitate the crossing of tight stenoses.
The provided text describes a Special 510(k) Summary for the ELM PTA Balloon Dilatation Catheter, focusing on demonstrating substantial equivalence to a previously cleared device (K102645). This type of submission is for modifications to an already cleared device, not for a new device requiring extensive clinical trials for performance validation. Therefore, the study described is primarily focused on design verification and validation testing rather than human clinical trials or AI algorithm performance studies.
Here's the breakdown of the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics like accuracy, sensitivity, or specificity. Instead, it refers to "design verification and validation testing" performed according to ISO 10993 Part 1 for biocompatibility and a list of specific engineering tests. The "reported device performance" is implicitly that the device met these engineering test criteria, allowing for a substantial equivalence determination.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility (ISO 10993 Part 1) | Devices determined to be biocompatible. |
| Balloon burst and compliance | (Implied: Met pre-defined engineering specifications for burst and compliance.) |
| Multiple inflation | (Implied: Met pre-defined engineering specifications for multiple inflation cycles.) |
| Catheter and packaging inspection | (Implied: Met pre-defined engineering specifications for inspection.) |
| Balloon inflation and deflation | (Implied: Met pre-defined engineering specifications for inflation/deflation characteristics.) |
| Bond tensile testing | (Implied: Met pre-defined engineering specifications for bond strength.) |
| Catheter performance testing | (Implied: Met pre-defined engineering specifications for overall catheter performance.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a distinct "test set" sample size in terms of clinical cases or patient data. The tests performed are described as "non-clinical design verification/validation tests and analyses." These tests typically involve a sample of manufactured devices (e.g., a certain number of catheters for burst testing, or a specific quantity of material for biocompatibility). The exact number of units or samples tested for each engineering parameter is not mentioned.
- Data Provenance: The data provenance is from non-clinical design verification/validation testing conducted by the manufacturer, Creagh Medical, in Ireland. It is not patient or human data, so terms like "retrospective" or "prospective" do not apply in a clinical sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Ground truth as defined by expert consensus or interpretations is not applicable here, as the study is a non-clinical device validation. The "ground truth" for these engineering tests would be established by validated test methods, industry standards (e.g., ISO), and internal specifications, not by human expert interpretation of clinical data. Therefore, no experts in a clinical context were used for this purpose.
4. Adjudication Method for the Test Set
Adjudication methods like "2+1" or "3+1" are relevant for expert review of clinical cases. Since this study involves non-clinical engineering tests, these methods are not applicable. The "adjudication" for these tests would involve comparing test results against pre-defined engineering specifications and acceptance criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This type of study (comparing human readers with and without AI assistance) is relevant for AI algorithms interpreting medical images, not for evaluating the mechanical performance of a medical device like a balloon catheter.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone study, implying an AI algorithm's performance, was not conducted. The device in question is a physical medical instrument (a catheter), not a software algorithm.
7. Type of Ground Truth Used
The "ground truth" for the non-clinical engineering tests was based on:
- Engineering Specifications: Internal design requirements and performance limits for the device.
- Industry Standards: Compliance with relevant international standards, such as ISO 10993 Part 1 for biocompatibility.
- Validated Test Methods: Established laboratory procedures for measuring characteristics like burst pressure, tensile strength, and inflation/deflation times.
8. Sample Size for the Training Set
A "training set" as understood in machine learning (used to train an AI algorithm) is not applicable here. The device does not involve an AI algorithm, and the manufacturing process does not typically involve a "training set" of data in this context. The production and testing are based on established engineering principles and quality control.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI algorithm.
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2.5 510(k) Summarv
This Special 510(k) Summary is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
1. General Information
Creagh Medical Submitter: IDA Business Park, Ballinasloe, Co. Galway, Ireland Telephone Number: 011 353 909 646300 011 353 909 646330 Fax Number: Eoin McEvoy Contact Person: 17th December 2011 Summary Preparation Date:
Device Information 2.
| Device Trade Names: | ELM PTA Balloon Dilatation Catheter |
|---|---|
| Common Name: | PTA Balloon Dilatation Catheter |
| Classification Name: | Catheter, Angioplasty, Peripheral, Transluminal(21 CFR 870.1250. Product Code: DQY, LIT) |
3. Predicate Device
ELM PTA Balloon Dilatation Catheter predicate
| Device Name: | ELM PTA Balloon Dilatation Catheter |
|---|---|
| 510(k) Clearance Number: | K102645 |
Device Description ধে
The ELM is a coaxial PTA Balloon Dilatation 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 dilating section of the balloon and aid in the balloon placement. The marker bands also indicate the nominal length of the balloon. The catheter tip is designed to ease entry into the peripheral arteries and to facilitate the crossing of tight stenoses.
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5. Indications for Use
The ELM PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.
6. Substantial Equivalence
This Special 510(k) submission aims to demonstrate substantial equivalence of the ELM PTA Balloon Dilatation Catheter with extended range through comparison with the predicate devices - ELM PTA Balloon Dilatation Catheter. The modified device introduces 16 product codes with lower Rated Burst Pressures (RBP) to the existing product matrix. There have been no changes to the intended use, indications or contraindications, as described in the labeling. There have been no other technological changes or changes to the final product specifications other than those noted above with respect to the rated burst pressure. There have been no changes to the sterilization method or to the packaging of the device. Substantial equivalence is demonstrated for the intended use of the ELM device. Where substantial equivalence is not directly demonstrated from the perspective of technology and performance, design verification testing provides evidence of the sbustantial equivalence of the ELM device.
7. Performance Data
The substantial equivalence of the ELM PTA Balloon Dilatation Catheter with extended range to the ELM PTA Balloon Dilatation Catheter cleared in K102645 has been demonstrated through data collected from non-ciinical design verification/validation tests and analyses. The devices have been tested according to ISO 10993 Part 1 and were determined to be biocompatible. The following design verification and validation testing was performed:
-
- Balloon burst and compliance
- . Multiple inflation
- . Catheter and packaging inspection
- Balloon inflation and deflation .
- . Bond tensile testing
- . Catheter performance testing.
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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 stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. The graphic is enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC 2 0 2011
Creagh Medical Ltd. c/o Maureen O'Connell President O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864
Re: K113468
Trade/Device Name: ELM PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Codes: LIT, DQY Dated: November 18, 2011 Received: November 22, 2011
Dear Ms. O'Connell:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PM), it may be subject to 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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean
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Page 2 - Ms. Maureen O'Connell
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
F. Brent Zuckerman, M.D.
Bram Luckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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2.4 Indications for Use
KIJ3468 510(k) Number (if known):
Device Name: ELM PTA Balloon Dilatation Catheter
Indications For Use:
The ELM PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and the renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.
Prescription Use X (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)
F.C. for BDE
ovascular Devices
510(k) Number K113468
§ 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).