(179 days)
The ReFORM Peripheral Catheter System is intended for use in atherectomy of the peripheral vasculature. The catheter is not intended for use in the coronary or carotid vasculature.
The ReFORM Peripheral Catheter System consists of two major components which are packaged separately but used together during atherectomy procedures. The two components are the ReFORM Peripheral Catheter and the ReFORM Cutter Driver.
The ReFORM Peripheral Catheter is comprised of a long, low-profile shaft at the end of which is a small mechanical cutter. The catheter is a monorail design which allows a single operator to insert and remove the device from the patient while maintaining guidewire position. A Cutter Driver controls the actuation of the cutting element. Excision of atheroma from the vessel is accomplished by a small spinning cylindrical blade contained within a cylindrical housing. Once the catheter is tracked to the target lesion, the tip is deflected, moving the cutter against the lesion. As the cutting blade spins, the device is advanced through the lesion, "shaving" plaque from the vessel wall. As the tissue is cut, it enters the device through a small opening just distal to the blade and is captured in the catheter tip and removed from the patient.
ReFORM Peripheral Catheters consist of a braided drive shaft inside a Pebax/Nylon outer shaft, connecting to the cylindrical cutter and cylindrical cutter housing. The soft, flexible tip also provides an area for tissue collection. At the end of each cutting pass, the cutter advances into the soft tip "packing" tissue into the nosecone. The cutter housing is radiopaque due to plating with platinum which allows it to serve as an angiographic marker for easy positioning of the cutter blade within the lesion. ReFORM Peripheral Catheter System configurations covered under the subject 510(k) Premarket Notification include 7 F and 8 F sheath compatible diameter catheters in lengths of 135 cm and110 cm respectively.
The provided 510(k) summary for the ReFORM™ Peripheral Catheter System (K024243) focuses on demonstrating substantial equivalence to a predicate device, the Simpson Peripheral Atherocath. This type of submission relies heavily on comparisons of intended use, technological characteristics, and non-clinical performance data, rather than detailed acceptance criteria and standalone clinical studies with specific performance metrics as might be found in a De Novo or PMA submission for a novel device.
Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test and training sets, ground truth establishment methods, expert qualifications, and MRMC studies is not explicitly available or applicable in the provided document. The submission's approach is to establish equivalence through a lack of significant differences that would raise new questions of safety or effectiveness.
Here's an analysis based on the available information:
Acceptance Criteria and Study for ReFORM™ Peripheral Catheter System (K024243)
The provided submission is a 510(k) premarket notification, which seeks to demonstrate "substantial equivalence" to a legally marketed predicate device. In this context, "acceptance criteria" are interpreted as showing that the new device is as safe and effective as the predicate, without raising new questions of safety or effectiveness. The "study" largely consists of non-clinical performance testing and a comparison of technological characteristics to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) summary relying on substantial equivalence, specific numeric acceptance criteria for performance metrics are not explicitly stated in the provided text in the way they might be for a novel device with defined performance endpoints. Instead, acceptance is implied by demonstrating that the device performs comparably to the predicate or meets established standards for devices of its type.
| Category | Acceptance Criteria (Implied by Substantial Equivalence Logic) | Reported Device Performance (Summary from 510(k)) |
|---|---|---|
| Intended Use | Identical to the approved indication for the predicate device: Atherectomy of the peripheral vasculature, not intended for coronary or carotid vasculature. | Identical to Predicate: "The intended use of the ReFORM Peripheral Catheter System is identical to the approved indication for the Simpson Peripheral Atherocath... Both the ReFORM Peripheral Catheter System and the Atherocath™ are designed for atherectomy of the peripheral vasculature and neither is intended for use in the coronary or carotid vasculature." |
| Method of Operation | Same general method of operation as the predicate device (mechanical excision of atheroma). | Same General Method: "As compared to the predicate device the ReFORM Peripheral Catheter System has the same indications for use, the same general method of operation..." Device mechanism described: small spinning cylindrical blade contained within a cylindrical housing, deflects tip to move cutter against lesion, shaves plaque, tissue enters device through opening and is captured in catheter tip and removed. |
| Device Classification | Same device classifications and codes as the predicate device. | Same Classification: "As compared to the predicate device the ReFORM Peripheral Catheter System... has the same device classifications and device codes." Classified as Catheter, Peripheral, Atherectomy (Product Code: MCW). |
| Patient Contact Materials | Comprised of the same general patient contact materials as the predicate. | Same General Materials: "As compared to the predicate device the ReFORM Peripheral Catheter System... is comprised of the same general patient contact materials..." Specifically mentions "braided drive shaft inside a Pebax/Nylon outer shaft." |
| Sterility | Provided sterile, consistent with the predicate and regulatory requirements. | Provided Sterile: "As compared to the predicate device the ReFORM Peripheral Catheter System... is provided sterile..." |
| Single Use | Designed for single use, consistent with the predicate. | Single Use: "As compared to the predicate device the ReFORM Peripheral Catheter System... is for single use..." |
| Biocompatibility | Must meet biocompatibility requirements (21 CFR Part 58). | Conformed to Requirements: "All applicable testing conformed to the requirements of 21 CFR Part 58 (Good Laboratory Practices) specifically, tests included biocompatibility..." No specific values are given, but compliance is stated. |
| Reliability | Must meet reliability requirements (21 CFR Part 58). | Conformed to Requirements: "All applicable testing conformed to the requirements of 21 CFR Part 58 (Good Laboratory Practices) specifically, tests included... reliability..." No specific values are given, but compliance is stated. |
| Functional Performance | Must demonstrate functional performance comparable to the predicate device and meet general performance expectations for an atherectomy catheter. | Performed and Compared: "Performance testing to support the safety and efficacy of the ReFORM Peripheral Catheter System has been performed and presented in the body of this 510(k). In addition, testing has been performed comparing the performance of the ReFORM Peripheral Catheter System with the DVI Simpson Atherocath™." No specific performance data (e.g., cutting efficiency, tissue collection volume, deflection force) are provided in the summary, but the existence of such testing is affirmed. |
| Clinical Equivalence | Expected to require minimal new clinical data due to substantial equivalence in indications, operation, materials, etc. Human clinical study safety data included. | Minimal Clinical Data Required: "As compared to the predicate devices the ReFORM Peripheral Catheter System has the same indications for use, the same general method of operation, is also for single use, is provided sterile, is comprised of the same general patient contact materials, and has the same device classifications and device codes therefore we believe minimal new clinical data is required. Animal test data and human clinical study safety data are included in the body of the submission." No specific results or sample sizes for human clinical data are provided in the summary. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified in the summary for any specific performance tests. The document broadly states "Performance testing... has been performed and presented in the body of this 510(k)." For the "human clinical study safety data," the sample size is also not specified.
- Data Provenance: Not specified (e.g., country of origin). The studies appear to be prospective in nature, as they involve testing a new device and animal studies, "human clinical study safety data" implies a controlled study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable or provided in the context of this 510(k) submission. Ground truth establishment by experts is typically relevant for diagnostic devices or AI algorithms where subjective interpretation is involved. For a mechanical atherectomy catheter, performance is assessed through engineering tests and clinical safety data, not expert consensus on images or clinical classifications.
4. Adjudication Method for the Test Set
This is not applicable or provided. Adjudication methods (like 2+1 or 3+1) are typically used in studies involving expert interpretation of data (e.g., imaging studies) to resolve disagreements and establish ground truth.
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
This is not applicable. An atherectomy catheter is a therapeutic/interventional device, not a diagnostic imaging device or an AI-powered tool that assists human readers. Therefore, an MRMC study is not relevant to its evaluation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical, mechanical catheter, not an algorithm.
7. The Type of Ground Truth Used
For a mechanical device, "ground truth" typically refers to objective measurements or observations from engineering tests and clinical outcomes.
- Engineering/Performance Data: Measurement of device attributes (e.g., cutting efficiency, material properties, dimensions, force resistance, tissue collection).
- Biocompatibility: Established by testing against ISO standards or similar benchmarks.
- Clinical Safety Data: Observation of adverse events, device malfunctions, and patient outcomes in animal studies and a human clinical safety study. The details of what specifically constituted "ground truth" (e.g., histology of treated vessels, specific adverse event rates) are not provided in the summary.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" as this is a mechanical medical device, not a machine learning model.
9. How the Ground Truth for the Training Set was Established
This is not applicable for the reasons stated above.
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JUN 2 0 2003
510(k) Summary
| Category: | Comments |
|---|---|
| Sponsor: | Fox Hollow Technologies Inc.300 Saginaw DriveRedwood City, CA 94063 |
| Correspondent: | Suzon LommelVice President Regulatory Affairs/QualityAssurance300 Saginaw DriveRedwood City, CA 94063 |
| Contact Numbers: | Phone: | Fax: |
|---|---|---|
| 650-568-2521 | 650-364-2315 | |
| Device Common Name: | Catheter, Atherectomy, Peripheral | |
| Device Proprietary Name: | ReFORM™ Peripheral Catheter System | |
| Device Classification Name: | Catheter, Angioplasty, Peripheral,Transluminal | |
| Device Classification: | Device: Catheter, Angioplasty, Peripheral,Transluminal orDevice: Catheter, Peripheral, AtherectomyProduct Code: MCW510(k) exempt: No | |
| Predicate Device | Simpson Peripheral Atherocath | |
| Predicate Device Manufacturer(s) | Devices for Vascular Intervention | |
| Predicate Device Reference(s) | K871011, K874706, K881088, K883346 | |
| Predicate Device Proprietary Name(s) | Simpson Peripheral Atherocath | |
| Predicate Device Classification Name(s) | Catheter, Angioplasty, Peripheral,Transluminal | |
| Predicate Device Classification(s) | Product Code: LIT |
Date Summary Was Prepared: Wednesday, December 18, 2002.
Description of the Device: The ReFORM Peripheral Catheter System consists of two major components which are packaged separately but used together during atherectomy procedures. The two components are the ReFORM Peripheral Catheter and the ReFORM Cutter Driver.
The ReFORM Peripheral Catheter is comprised of a long, low-profile shaft at the end of which is a small mechanical cutter. The catheter is a monorail design which allows a single operator to insert and remove the device from the patient while maintaining guidewire position. A Cutter Driver controls the actuation of the cutting element. Excision of atheroma from the vessel is accomplished by a small spinning cylindrical blade contained within a cylindrical housing. Once the catheter is tracked to the target lesion, the tip is deflected, moving the cutter against the lesion. As the cutting blade spins, the device is advanced through
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the lesion, "shaving" plaque from the vessel wall. As the tissue is cut, it enters the device through a small opening just distal to the blade and is captured in the catheter tip and removed from the patient.
Intended Use: The intended use of the ReFORM Peripheral Catheter System is identical to the approved indication for the Simpson Peripheral Atherocath™, which was found to be substantially equivalent to the Dotter Transluminal Dilatation Catheter, Percutaneous Transluminal Angioplasty Balloon Dilatation Catheters and Intraluminal Arterial Strippers (K871011 - May 14, 1987). Both the ReFORM Peripheral Catheter System and the Atherocath™ are designed for atherectomy of the peripheral vasculature and neither is intended for use in the coronary or carotid vasculature.
Technological Characteristics: ReFORM Peripheral Catheters consist of a braided drive shaft inside a Pebax/Nylon outer shaft, connecting to the cylindrical cutter and cylindrical cutter housing. The soft, flexible tip also provides an area for tissue collection. At the end of each cutting pass, the cutter advances into the soft tip "packing" tissue into the nosecone. The cutter housing is radiopaque due to plating with platinum which allows it to serve as an angiographic marker for easy positioning of the cutter blade within the lesion. ReFORM Peripheral Catheter System configurations covered under the subject 510(k) Premarket Notification include 7 F and 8 F sheath compatible diameter catheters in lengths of 135 cm and110 cm respectively.
Comparison to Predicate Devices: As compared to the predicate device the ReFORM Peripheral Catheter System has the same indications for use, the same general method of operation, is for single use, is provided sterile, is comprised of the same general patient contact materials, and has the same device classifications and device codes.
Summary of the Non-Clinical Performance Data: Performance testing to support the safety and efficacy of the ReFORM Peripheral Catheter System has been performed and presented in the body of this 510(k). In addition, testing has been performed comparing the performance of the ReFORM Peripheral Catheter System with the DVI Simpson Atherocath™.
Clinical Data: As compared to the predicate devices the ReFORM Peripheral Catheter System has the same indications for use, the same general method of operation, is also for single use, is provided sterile, is comprised of the same general patient contact materials, and has the same device classifications and device codes therefore we believe minimal new clinical data is required. Animal test data and human clinical study safety data are included in the body of the submission.
Summary of the Non-clinical General Data: All applicable testing conformed to the requirements of 21 CFR Part 58 (Good Laboratory Practices) specifically, tests included biocompatibility, reliability, sterility and functional performance.
510(k) – ReFORM™ Peripheral Catheter System
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, with three curved lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 0 2003
FoxHollow™ Technologies c/o Ms. Suzon Lommel Vice President Regulatory Affairs/Quality Assurance 300 Saginaw Drive Redwood City, California 94063-4743
Re: K024243
Trade Name: Reform Peripheral Catheter System Regulation Number: 21 CFR § 870.4875 Regulation Name: Intraluminal artery stripper Regulatory Class: II (two) Product Code: MCW Dated: April 1, 2003 Received: April 3, 2003
Dear Ms. Lommel:
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.
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
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Page 2 - Ms. Suzon Lommel
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 (301) 594-4646. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Kaler TM
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement:
Ver. 3 - 4/24/96
Applicant: Fox Hollow Technologies, Inc.
510(k) Number (if known):
Device Name: FHT Peripheral Debulking System
Indications For Use:
The ReFORM Peripheral Catheter System is intended for use in atherectomy of the
peripheral vasculature. The catheter is not intended for use in the coronary or carotid
vasculature.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Prescription Use Only
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number. K024243
510(k) - ReFORM™ Peripheral Catheter System
§ 870.4875 Intraluminal artery stripper.
(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).