(192 days)
The LipiScan Coronary Imaging System is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. The System is intended for the detection of lipid-core-containing plaques of interest. The System is intended for the assessment of coronary artery lipid core burden.
The LipiScan Coronary Imaging System is comprised of the catheter, catheter accessories, pull-back and rotation device and laser console with accessories.
The provided text describes a 510(k) summary for the LipiScan Coronary Imaging System. However, it does not contain specific acceptance criteria or details of a study that directly proves the device meets such criteria. The document focuses on establishing substantial equivalence to a predicate device, highlighting similar intended use, operating principles, catheter design, shelf life, packaging, and compliance with general safety and performance standards.
Here's an analysis based on the information provided and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Not explicitly provided in the document. The 510(k) summary states, "Further preclinical testing has shown that the product can function as intended and meets all internal design specifications," but it does not list these specifications or acceptance criteria. There are no quantitative performance metrics (e.g., sensitivity, specificity, accuracy for detecting lipid-core-containing plaques) presented as acceptance criteria or reported device performance.
2. Sample Size Used for the Test Set and Data Provenance
Not explicitly provided for any specific performance study. The document mentions "Ex vivo and in vivo data is presented to support expanded indications for use," but no details about the sample size, type of test set, or data provenance (e.g., country of origin, retrospective/prospective) are given for these studies.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not explicitly provided. Since no specific performance study with a test set is detailed, information about experts, their number, or their qualifications for establishing ground truth is absent.
4. Adjudication Method for the Test Set
Not explicitly provided. As no specific performance study is detailed, there is no information about any adjudication methods (e.g., 2+1, 3+1).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not mentioned and likely not performed or reported in this summary. The document focuses on demonstrating substantial equivalence, not on comparative effectiveness with or without AI assistance. The device is for imaging, and there's no mention of AI assistance for human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable/not described. The LipiScan Coronary Imaging System is presented as an imaging system that provides an image of the artery wall. It's a diagnostic tool intended for use by clinicians, not an autonomous AI algorithm. Therefore, a "standalone algorithm only" performance study is not relevant in the context described.
7. Type of Ground Truth Used
Not explicitly stated for specific performance evaluations. The summary does not detail the nature of the ground truth for any studies supporting "expanded indications for use." For such devices, ground truth might involve histology, pathology, or correlative imaging modalities, but this is not specified here.
8. Sample Size for the Training Set
Not applicable/not provided. The device is an imaging system, not explicitly an AI/machine learning algorithm that requires a training set in the conventional sense. The "preclinical testing" and "ex vivo and in vivo data" likely refer to validation and verification testing for safety and performance, not training data for a learning model.
9. How the Ground Truth for the Training Set Was Established
Not applicable/not provided. As explained in point 8, there's no mention of a training set or an AI algorithm that would necessitate establishing ground truth for training.
In summary, the provided 510(k) summary serves to demonstrate substantial equivalence to predicate devices and adherence to general safety and performance standards. It mentions "preclinical testing" and "ex vivo and in vivo data" to support its expanded indications, but it lacks the detailed information about specific acceptance criteria and the comprehensive study methodology asked for in the prompt. This level of detail is often found in the full 510(k) submission, not typically in the public summary.
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| 510(K) SUMMARYLipiScan Coronary Imaging System | K072932Pg 1 of 2 | |
|---|---|---|
| Submitter Name: | InfraReDx, Inc. | |
| Submitter Address: | 34 Third AvenueBurlington, MA 01803 | APR 25 2008 |
| Contact Person: | Steven J. Chartier, Director, Clinical and Regulatory Affairs | |
| Phone Number: | (781) 221-0053, ext. 349 | |
| Fax Number: | (781) 272-5290 | |
| Date Prepared: | April 21, 2008 | |
| Device Trade Name: | LipiScan Coronary Imaging System | |
| Device Common Name: | Near Infrared Imaging System | |
| Predicate Devices: | InfraReDx NIR Imaging System (K052908)Boston Scientific Galaxy IVUS System (K980851), BostonScientific Atlantis SR Pro (K050577)Volcano Eagle Eye Gold IVUS catheter (K051337), IVUSsystem (K042188) | |
| Device Description: | The LipiScan Coronary Imaging System is comprised ofthe catheter, catheter accessories, pull-back and rotationdevice and laser console with accessories. | |
| Intended Use: | The LipiScan Coronary Imaging System is intended for thenear-infrared examination of coronary arteries. The Systemis intended for the detection of lipid-core-containingplaques of interest. The System is intended for theassessment of coronary artery lipid core burden. |
Device Technology Characteristics and Comparison to Predicate Device:
The LipiScan Coronary Imaging System utilizes the same basic catheter design as the predicate, the InfraReDx NIR Imaging System, cleared K052809. These devices have a similar intended use, use the same operating principal, incorporate the same basic catheter design, have the same shelf life, and are packaged using the same materials and processes. The modifications from the InfraReDx NIR Imaging System to the LipiScan Coronary Imaging System are the improved catheter design, improved user interface (including PBR and console), and the additional testing required to support an expanded indication for use.
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K072932
Pg. 2 of 2
The LipiScan Coronary Imaging System complies with Performance Data: applicable safety and performance standards, ISO 60601-1, ISO 60601-2-22, CSA22.2 No.601.1, CSA Z386-01, IEC 60825-1, ANSI Z136.1-2000 and ISO 10993 (for transient blood contacting devices). Further preclinical testing has shown that the product can function as intended and meets all internal design specifications.
Conclusion: The LipiScan Coronary Imaging System has similar indications statements as the predicate devices. All are used for imaging of the coronary vasculature. The functionality of the LipiScan Coronary Imaging System and predicate devices is identical. The catheter accesses the coronary vasculature via the femoral or radial access site and tracks on the existing guidewire as used during routine PCI. The device output is an image of the artery wall, as an adjunct to coronary angiography, and is similar to the predicate devices. Ex vivo and in vivo data is presented to support expanded indications for use. Therefore the LipiScan Coronary Imaging System is substantially equivalent to the predicate devices.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 5 2008
InfraReDx, Inc. c/o Mr. Steven J. Chartier Director, Clinical and Regulatory Affairs 34 Third Ave. Burlington, MA 01803
Re: K072932
Trade/Device Name: LipiScan Coronary Imaging System Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II (two) Product Code: OGZ Dated: March 5, 2008 Received: March 6, 2008
Dear Mr. Chartier:
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 - Mr. Steven J. Chartier
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.
Sincerely yours,
B.Bummeuraylor
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
510(k) Number: K072932
Device Name:
LipiScan Coronary Imaging System
Indications for Use:
The LipiScan Coronary Imaging System is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. The System is intended for the detection of lipid-core-containing plaques of interest. The System is intended for the assessment of coronary artery lipid core burden.
X Perscription Use (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 A ANOTHER PAGE IF NECESSARY)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| (Division Sign-Off) | |
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| Division of Cardiovascular Devices | |
| 510(k) Number | K072932 |
Section 4: Page lof 1
§ 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).