(62 days)
The PolarCath™ Peripheral Dilatation System is indicated to dilate stenoses in the peripheral vasculature (iliac, femoral, popliteal, infrapopliteal, renal and subclavian arteries) and for the treatment of obstructive lesions of polytetrafluoroethylene (PTFE) access grafts or arteriovenous dialysis fistulae. The PolarCath™ Peripheral Dilatation System is also indicated for post-deployed stent expansion of self-expanding peripheral vascular stents.
The PolarCath™ Peripheral Dilatation System consists of a Catheter, Inflation Unit, connecting cable and a rechargeable battery pack with recharging unit and battery receptacle. The inflation medium (liquid nitrous oxide) is provided in a disposable 14 gram cartridge.
The provided text describes a 510(k) premarket notification for a modification to the PolarCath™ Peripheral Dilatation System, specifically focusing on changes to the Inflation Unit's circuit board. This filing is for a device modification and does not involve a study to establish the diagnostic or predictive performance of an AI/ML algorithm. Therefore, many of the requested elements pertaining to such studies are not applicable.
Here's an analysis of the provided information in the context of the requested questions:
1. A table of acceptance criteria and the reported device performance
Since this is a submission for a modification to an existing device, the "acceptance criteria" are related to ensuring the modified device performs equivalently to the predicate device. The performance reported here relates to the safety and functionality of the changed component.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Maintain equivalent function of inflation units and circuitry | Successful completion of verification testing which assessed the function of inflation units and their circuitry through 12 sequential runs, or inflations, of the balloon. The changes "have been proven not to adversely affect the function of the device." |
| No adverse effect on overall design, function, material, intended use, labeling, or directions for use compared to the predicate device | No adverse effects reported. The changes only affect the Inflation Unit circuit board and not other aspects of the device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The information states "12 sequential runs, or inflations, of the balloon" were performed during verification testing. This implies a sample size of 12 tests on the modified inflation units. There is no information provided about the country of origin or whether the data was retrospective or prospective. This type of testing is typically prospective, performed in a controlled lab setting, rather than on patient data.
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 is not applicable. The "ground truth" for this type of engineering verification testing would be the pre-defined functional specifications of the device, assessed by engineers or technicians, not clinical experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as there's no clinical "ground truth" being established by experts through adjudication for this type of engineering verification. The assessment would likely involve comparing device output/functionality against engineering specifications.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for a physical device modification, not an AI/ML algorithm that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This submission is for a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this verification testing would be the functional specifications and performance parameters of the device's inflation unit and circuitry. It would be measured against engineering benchmarks, not clinical outcomes or expert consensus.
8. The sample size for the training set
This is not applicable. There is no "training set" as this is a physical device modification, not a machine learning model.
9. How the ground truth for the training set was established
This is not applicable for the same reason as above.
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ATTACHMENT 4
JUN 1 3 2007
510(k) Summary
per 21 CFR §807.92
| Submitter's Name and Address | Boston Scientific CorporationOne Scimed PlaceMaple Grove, MN 55311 |
|---|---|
| Contact Name and Information | Monica MorrisonRegulatory AffairsPhone: (763) 494-2676Fax: (763) 494-2981Email: morrisom@bsci.com |
| Date Prepared | April 11, 2007 |
| Proprietary Name(s) | PolarCath™ Peripheral Dilatation System |
| Common Name | Percutaneous Transluminal Angioplasty Catheter |
| Product Code | LIT/DQY |
| Classification of Device | Class II, 21 CFR Part 870.1250 |
| Predicate Device | PolarCath™ Peripheral Dilatation System K062594 September 28, 2006 |
| Device Description | The PolarCath™ Peripheral Dilatation System consists of a Catheter, Inflation Unit, connecting cable and a rechargeable battery pack with recharging unit and battery receptacle. The inflation medium (liquid nitrous oxide) is provided in a disposable 14 gram cartridge. |
| Intended Use of Device | The PolarCath™ Peripheral Dilatation System is indicated to dilate stenoses in the peripheral vasculature (iliac, femoral, popliteal, infrapopliteal, renal and subclavian arteries) and for the treatment of obstructive lesions of polytetrafluoroethylene (PTFE) access grafts or arteriovenous dialysis fistulae. The PolarCath™ Peripheral Dilatation System is also indicated for post-deployed stent expansion of self-expanding peripheral vascular stents. |
:
CONFIDENTIAL
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| Comparison ofTechnologicalCharacteristics | The proposed changes to the PolarCath™ Peripheral DilatationSystem apply only to the circuit board within the Inflation Unit.These changes include the addition of resistors, fuses, capacitors,a voltage suppressor and an update to the circuit board layout.There are no changes to the other materials or design elements ofthis product as compared to the currently cleared PolarCath™Peripheral Dilatation System. |
|---|---|
| Support ofSubstantialEquivalence | Boston Scientific Corporation considers the proposed PolarCath™Peripheral Dilatation System to be substantially equivalent to theexisting PolarCath™ Peripheral Dilatation System (K062594,Cleared September 28, 2006). This assessment is based upon thesuccessful completion of verification testing (refer to Section 5.2and Attachment 3) which assessed the function of inflation unitsand their circuitry through 12 sequential runs, or inflations, of theballoon. In addition, there have been no changes to the overalldesign, function, material, intended use, labeling, or directions foruse of the PolarCath™ Peripheral Dilatation System. The changesonly affect the Inflation Unit circuit board and have been provennot to adversely affect the function of the device. |
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three heads, representing the three branches of government. The eagle is surrounded by a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 3 2007
Boston Scientific Corp. c/o Ms. Monica Morrison Regulatory Affiars One Scimed Place Maple Grove, MN 55311
Re: K071042
PolarCath™ Peripheral Dilation System Regulation Number: 21 CFR 870.1250 Regulation Name: Peripheral Dilation Catheter Regulatory Class: Class II Product Code: LIT/DQY Dated: April 16, 2007 Received: May 29, 2007
Dear Ms. Morrison:
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.
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Page 2 - Ms. Monica Morrison
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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.
Sincerety Jours,
R
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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ATTACHMENT 2
Indications for Use Statement
K071042 510(k) Number:
PolarCath™ Peripheral Dilatation System Device Name:
Indications for Use:
The PolarCath™ Peripheral Dilatation System is indicated to dilate stenoses in the peripheral vasculature (iliac, femoral, popliteal, infrapopliteal, renal and subclavian arteries) and for the treatment of obstructive lesions of polytetrafluoroethylene (PTFE) access grafts or arteriovenous dialysis fistulae. The PolarCath™ Peripheral Dilatation System is also indicated for post-deployed stent expansion of self-expanding peripheral vascular stents.
Prescription Use X (part 21 CFR 801 Subpart D)
AND/OR .
Over-the-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Divisio S/C
Division S/m-On)
Division of Cardiovascular Devices
510(k) Number K071042
Boston Scientific Corporation
CONFIDENTIAL
PolarCath™ Peripheral Dilatation System Page 11 of 14
§ 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).