(100 days)
The IMAGER™II Angiographic Catheters are indicated for use to provide a pathway for delivering contrast media to selected sites in the vascular system.
The IMAGER™II Angiographic Catheters are designed to provide a pathway for delivering contrast media to selected sites in the vascular system. The IMAGER™II Angiographic Catheters are sterile, single-use diagnostic intravascular catheters and are available in a variety of flush and selective shapes with lengths of 40 cm, 65 cm, 90cm and 100 cm. The distal segment of the catheter is radiopaque to aid in visualization of the device under fluoroscopy.
The provided document is a 510(k) summary for a medical device (Imager II Angiographic Catheter) seeking substantial equivalence to a predicate device. It primarily discusses regulatory compliance and biocompatibility. It does not present a study proving the device meets specific performance acceptance criteria in the way a clinical trial or algorithm validation study would.
Instead, the document states that the device has been tested and compared to a predicate device, and all data gathered demonstrate substantial equivalence. The "acceptance criteria" here are geared towards regulatory approval rather than clinical performance metrics.
Therefore, many of the requested details about statistical studies, sample sizes, ground truth establishment, and expert involvement are not available in this type of regulatory submission.
Here's an analysis based on the information provided, highlighting what is (and isn't) present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from 510(k) Summary) | Reported Device Performance (from 510(k) Summary) |
|---|---|
| Biocompatibility: Device materials are biocompatible for intended use. | "The IMAGER™II Angiographic Catheters have been tested for biocompatibility per ISO 10993. All data demonstrate this device is biocompatible for its intended use." |
| Substantial Equivalence: Device is substantially equivalent to the NightHawk Angiographic Catheter (predicate device), with no new safety or efficacy issues. | "The IMAGER™II Angiographic Catheters have been tested and compared to the predicate device. All data gathered demonstrate this device as substantially equivalent. No new issues of safety or efficacy have been raised." |
| Intended Use: Provides a pathway for delivering contrast media to selected sites in the vascular system. | This is the stated intended use; functionality is implied to meet this by substantial equivalence to the predicate. |
| Device Characteristics: (e.g., shapes, lengths, radiopacity consistent with predicate) | "Available in a variety of flush and selective shapes with lengths of 40 cm, 65 cm, 90cm and 100 cm. The distal segment of the catheter is radiopaque to aid in visualization of the device under fluoroscopy." (Implied to be consistent with or improved over predicate characteristics). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified for any specific performance or equivalence testing. The 510(k) process relies on demonstrating equivalence through various engineering, performance, and biocompatibility tests, not typically a large-scale clinical "test set" as understood in AI/ML studies.
- Data Provenance: Not specified. Testing would have been conducted by the manufacturer, Boston Scientific/Medi-Tech, likely under controlled laboratory conditions, possibly involving internal tests and external contract labs for biocompatibility.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable in the context of this 510(k) submission. The ground truth for biocompatibility is established by ISO 10993 standards and testing protocols. For substantial equivalence, it's a comparison to the known performance and characteristics of the predicate device. There is no mention of human expert-labeled "ground truth" data sets.
4. Adjudication Method for the Test Set
- Not applicable. There is no mention of a formal adjudication process for interpreting test results in the way one would for clinical image reviews.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. This document describes a 510(k) submission for an angiographic catheter, which is a physical medical device. MRMC studies are typically performed for diagnostic imaging devices or AI-powered algorithms to assess human reader performance with and without assistance. This device does not fall into that category.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- For Biocompatibility: Established by international standards (ISO 10993) and the results of specific biological evaluations (e.g., cytotoxicity, sensitization, irritation tests).
- For Substantial Equivalence: Comparison to the known specifications, materials, and intended use of the legally marketed predicate device (NightHawk Angiographic Catheter).
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" in the context of this type of device and regulatory submission. This is not an AI/ML device.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As above, there is no AI/ML training set. Any internal developmental testing or engineering validation would have relied on established engineering principles, material science, and test methods.
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SEP - 7 2001
Special Special 510(k)
Imager II Angiographic Catheter
May 29, 2001
Summary of Safety and Effectiveness
| GeneralProvisions | Trade Name: Imager™ II Angiographic CatheterClassification Name: Diagnostic Intravascular Catheter |
|---|---|
| Name ofPredicateDevices | NightHawk Angiographic Catheter |
| Classification | Class II |
| PerformanceStandards | Performance Standards have not been established by FDA under Section 514of the Food, Drug and Cosmetic Act |
| Intended Useand DeviceDescription | The IMAGER™II Angiographic Catheters are designed to provide a pathwayfor delivering contrast media to selected sites in the vascular system. TheIMAGER™II Angiographic Catheters are sterile, single-use diagnosticintravascular catheters and are available in a variety of flush and selectiveshapes with lengths of 40 cm, 65 cm, 90cm and 100 cm. The distal segmentof the catheter is radiopaque to aid in visualization of the device underfluoroscopy. |
| Biocompatibility | The IMAGER™II Angiographic Catheters have been tested forbiocompatibility per ISO 10993. All data demonstrate this device isbiocompatible for its intended use. |
| Summary ofSubstantialEquivalence | The IMAGER™II Angiographic Catheters have been tested and compared tothe predicate device. All data gathered demonstrate this device assubstantially equivalent. No new issues of safety or efficacy have beenraised. |
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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or movement. The image is in black and white.
Public Health Service
SEP = 7 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Jodi Lynn Greenizen Boston Scientific/Medi-Tech® One Boston Scientific Place Natick, MA 01760-1537
Re: K011664
IMAGER™ II Angiographic Catheters Regulation Number: 870.1200 Regulatory Class: II (two) Product Code: DQO Dated: August 13, 2001 Received: August 14, 2001
Dear Ms. Greenizen:
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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (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 you might
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Page 2 - Ms. Jodi Lynn Greenizen
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 advertising 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 general information on your responsibilities under the Act may be obtained 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,
Dale Teh
James E. Dillard II Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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: 上
Indications For Use
| 510(k) Number (if known) | K011664 |
|---|---|
| Device Name: | IMAGER™II Angiographic Catheters |
| Indications for Use | The IMAGER™II Angiographic Catheters are indicated for use to provide a pathway for delivering contrast media to selected sites in the vascular system. |
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| Division510(k) Num | levices | |
|---|---|---|
| Prescription UseUse(Per 21 CFR 801.109) | OR | Over(Optio |
| Concurrence of CDRH, Office of Device Evaluation |
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§ 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).