(27 days)
The SCIMED EXPO and Impulse Angiographic Catheters are designed to provide a pathway to be used for delivering contrast media to selected sites in the vascular system during an angiographic procedure.
The modified SCIMED EXPO and Impulse angiographic catheters are the same as the SCIMED EXPO and Impulse angiographic catheters currently on the market with the exception of the new hub material.
The provided document describes a 510(k) submission for a device modification (K992142) for SCIMED EXPO and Impulse Angiographic Catheters. The modification is a change in the hub material. This submission focuses on demonstrating substantial equivalence to a predicate device, as opposed to proving overall effectiveness or providing a detailed study of an AI/ML algorithm's performance.
Therefore, many of the requested categories are not applicable to this type of regulatory submission. The document reports on functional testing and biocompatibility testing of the new hub material to ensure the modified device maintains its safety and effectiveness, but it does not describe an AI/ML device study.
Here's a breakdown of the requested information based on the provided text, indicating "Not Applicable" or "Not Provided" where the information is not present or relevant to a device modification submission of this nature:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance (as per document) |
|---|---|
| Integrity of Modified Hub | Functional testing conducted to verify integrity. (Specific quantitative criteria and performance not provided) |
| Biocompatibility | Biocompatibility testing conducted on the new hub material. (Specific criteria and results not provided) |
| Intended Use | Remains the same: "designed to provide a pathway to be used for delivering contrast media to selected sites in the vascular system during an angiographic procedure." |
| Technological Characteristics | Same as currently marketed EXPO and Impulse angiographic catheters. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not provided. The document mentions "functional testing" and "biocompatibility testing" but does not specify the number of units or samples tested.
- Data Provenance: Not applicable/Provided. This is a technical performance test, not a clinical data study with patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. Ground truth for functional and biocompatibility testing is typically established through direct measurement against predefined specifications, not expert consensus on clinical cases.
4. Adjudication Method for the Test Set
- Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not applicable. This device is an angiographic catheter, not an AI/ML diagnostic tool requiring MRMC studies for human reader improvement.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable. This device is a medical instrument, not an algorithm.
7. Type of Ground Truth Used
- Type of Ground Truth: For the functional testing, the ground truth would be the established performance specifications for the catheter (e.g., flow rates, pressure resistance, structural integrity). For biocompatibility, it would be the established safety standards for biological interaction (e.g., cytotoxicity, sensitization, irritation). These are determined through engineering and materials science standards.
8. Sample Size for the Training Set
- Not applicable. There is no AI/ML algorithm discussed that would require a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable. There is no AI/ML algorithm discussed.
Explanation for Limited Information:
The document is a 510(k) submission for a minor device modification (change in hub material for an angiographic catheter). For such submissions, the focus is on demonstrating that the new material does not negatively impact the device's safety and effectiveness compared to the predicate device. This is typically achieved through engineering tests (functional testing) and materials science tests (biocompatibility testing) rather than clinical studies or AI/ML evaluations. The provided text is a summary and does not delve into the detailed methodologies or quantitative results of these tests, which would be part of a more comprehensive submission not fully included here.
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K992M2
JUL 2 1 ਰਿਰੋਰੇ Special 510(k) : Device Modification SCIMED Angiographic Catheters Hub Material Change
Section 4
Summary of Safety and Effectiveness
.. ...
(Pursuant To Section 12 of the SAFE MEDICAL DEVICES ACT of 1990)
I. General Provisions
| Submitter's Nameand Address | Boston Scientific SCIMED, Inc.One SCIMED PlaceMaple Grove, Minnesota 55311 |
|---|---|
| Contact Person | Melanie Raska(612) 494-2962 |
| Classification Name | Diagnostic Intravascular Catheters(21CFR Part 870.1200) |
| Common or Usual Name | Diagnostic Intravascular Catheter |
| Proprietary Name | SCIMED® EXPO and ImpulseAngiographic Catheters |
| Name of Predicate Devices | SCIMED® EXPO and ImpulseAngiographic Catheters |
II. Device Description
The modified SCIMED EXPO and Impulse angiographic catheters are the same as the SCIMED EXPO and Impulse angiographic catheters currently on the market with the exception of the new hub material.
III. Intended Use
SCIMED EXPO and Impulse angiographic catheters are designed to provide a pathway to be used for delivering contrast media to selected sites in the vascular system during an angiographic procedure.
IV. Summary of Technological Characteristics
Same as currently marketed EXPO and Impulse angiographic catheters.
V. Non-clinical Test Summary
Functional testing was conducted to verify the integrity of the modified hub. Biocompatibility testing was conducted on the new hub material.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a series of flowing lines, possibly representing health and well-being.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 1 1999
Ms. Melanie Raska Regulatory Affairs Specialist Boston Scientific SCIMED, Inc. One Scimed Place Maple Grove, MN 55311-1566
Re: K992142 SCIMED EXPO and Impulse Angiographic Catheters Trade Name: Requlatory Class: II Product Code: DQO Dated: June 23, 1999 June 24, 1999 Received:
Dear Ms. Raska:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation
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Page 2 - Ms. Melanie Raska
you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertisinq of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Thomas J. Callshan
Thomas J. Callaha Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Special 510(k) : Device Modification SCIMED Angiographic Catheters Hub Material Change
Section 3
Indications for Use
510(k) Number (if known)
Device Name: SCIMED® EXPO and Impulse Angiographic Catheters
Indications for Use:
The SCIMED EXPO and Impulse Angiographic Catheters are designed to provide a pathway to be used for delivering contrast media to selected sites in the vascular system during an angiographic procedure.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ OR Over The Counter Use _
(Per 21 CFR 801.109)
(Division Sign Off) (Optional Format 1-2-96)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K99 2142
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).