(188 days)
- The LipiScan™ IVUS Imaging System is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography.
a. The System is intended for the detection of lipid-core-containing plaques of interest.
b. The System is intended for the assessment of coronary artery lipid core burden. - The System is intended for ultrasound examination of coronary intravascular pathology.
a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.
The InfraReDx LipiScan™ IVUS Imaging System is comprised of the catheter, catheter accessories, pull-back and rotation device and laser console with accessories.
The InfraReDx LipiScan™ IVUS Imaging System is designed for near-infrared examination of coronary arteries to detect lipid-core containing plaques and assess lipid core burden, as well as for ultrasound examination of coronary intravascular pathology.
The provided document, K093993, does not contain specific acceptance criteria or an evaluation study with quantitative performance metrics for the InfraReDx LipiScan™ IVUS Imaging System. The information focuses on demonstrating substantial equivalence to predicate devices based on design, intended use, operating principle, and safety testing.
Here's a breakdown of the information available and the aspects that are not available in the provided text:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the document. The submission details bench, electrical safety, and acoustic output testing, stating that the device "meet[s] or exceed[s] performance requirements" and that "the device satisfies all performance and functional requirements," but it does not specify what those quantitative requirements or acceptance criteria were, nor does it present specific performance values (e.g., sensitivity, specificity for lipid core detection, or quantitative accuracy metrics for IVUS measurements).
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The document mentions "Ex vivo and in vivo data is presented to support expanded indications for use." However, it does not provide any details regarding the sample size, data provenance (country of origin), or whether the data was retrospective or prospective for these studies.
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 information is not provided in the document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided in the document.
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 type of study is not mentioned in the document. The device is described as an imaging system, not an AI-assisted diagnostic tool in the context of comparative effectiveness with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not explicitly provided in the document, as the submission does not detail specific algorithm performance studies. The focus is on the integrated system's safety and functionality rather than standalone algorithmic performance metrics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The document states "Ex vivo and in vivo data is presented to support expanded indications for use." While it implies comparison to some form of ground truth, the specific type of ground truth (e.g., histological analysis for lipid cores, or a gold standard for IVUS measurements) is not detailed.
8. The sample size for the training set:
This information is not provided. The document describes software verification and validation, but not a "training set" in the context of machine learning or AI, which is a common use of the term.
9. How the ground truth for the training set was established:
This information is not provided as there is no mention of a training set or ground truth establishment for such a set.
Summary of available information related to performance and testing:
- Non-clinical Test Results: Bench, electrical safety, and acoustic output safety testing were performed.
- Bench Testing: Evaluated performance and functionality, including hardware and software unit-level tests and system-level tests. Results "demonstrate that the device satisfies all performance and functional requirements." (No specific criteria or performance values are given).
- Electrical Safety Testing: Complies with EN 60601-1 and EN 60601-1-2 standards, verified by independent test facilities.
- Software Verification and Validation: Performed in accordance with applicable FDA guidance documents.
- Acoustic Output Testing: Performed in accordance with FDA Guidance, "Information for Manufactures Seeking Market Clearance of Diagnostic Ultrasound Systems and Transducers", issued September 30, 1997.
- Ex vivo and in vivo data: Presented to support expanded indications for use. (No further details on these studies are provided).
In conclusion, while the document confirms various tests were conducted to ensure safety and functionality, it lacks the specific quantitative acceptance criteria, detailed study designs, sample sizes, and expert qualifications that would typically describe the device's performance against defined criteria. The submission focuses on substantial equivalence based on overall functionality and safety testing rather than a detailed performance study with quantifiable metrics against specific acceptance thresholds.
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K093993 pg. 1 of 3
Premarket Notification
510(K) SUMMARY
JUN 3 0 2010
| Submitter Name: | InfraReDx, Inc. |
|---|---|
| Submitter Address: | 34 Third AvenueBurlington, MA 01803 |
| Contact Person: | Steven J. Chartier, Vice President, Clinical & Regulatory Affairs |
| Phone Number: | (781) 345-9593 |
| Fax Number: | (781) 272-5290 |
| Date Prepared: | December 23, 2009 |
| Device Trade Name: | InfraReDx LipiScan™ IVUS Imaging System |
| Device Common Name: | Near Infrared/IVUS Imaging System |
| Predicate Devices: | InfraReDx LipiScan™ IVUS Imaging System (K072932)Boston Scientific iLab Ultrasound Imaging System(K051679), Boston Scientific Atlantis SR Pro Catheter(K050577) |
| Device Description: | The InfraReDx LipiScan™ IVUS Imaging System iscomprised of the catheter, catheter accessories, pull-backand rotation device and laser console with accessories. |
| Intended Use: | The LipiScan™ IVUS Imaging System is intended for thenear-infrared examination of coronary arteries in patientsundergoing invasive coronary angiography.a. The System is intended for the detection of lipid-core-containing plaques of interest.b. The System is intended for the assessment ofcoronary artery lipid core burden.The System is intended for ultrasound examination ofcoronary intravascular pathology. Intravascular ultrasoundimaging is indicated in patients who are candidates fortransluminal coronary interventional procedures. |
| Device Technology Characteristics and Comparison to Predicate Device: | The InfraReDx LipiScan™ IVUS Imaging System utilizesthe same basic catheter design as the predicate, theInfraReDx LipiScan™ Coronary Imaging System, Gen. 1.0cleared K072932. These devices have a similar intendeduse, use the same operating principal, incorporate thesame basic catheter design, have the same shelf life, andare packaged using the same materials and processes.The modifications from the InfraReDx LipiScan™ Coronary |
Section 5: Page 1 of 3
.
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Premarket Notification
Koszari 3 pa 2013
Imaging System, Gen. 1.0 to the InfraReDx LipiScan™ IVUS Imaging System are the inclusion of ultrasound imaging within the same dimensions of the catheter, and the additional testing required to support an expanded indication for use. The ultrasound capabilities are functionally equivalent to the Boston Scientific iLab System (K051679).
Performance Data:
Non-clinical Test Results
Bench, electrical safety and acoustic output safety testing demonstrate that the LipiScan™ IVUS System and its accessories meet or exceed performance requirements and is safe and effective for its intended use.
Bench Testing
Bench testing was performed to evaluate the performance and functionality of the LipiScan™ IVUS System. This testing included hardware unit-level tests, software unitlevel test, and system level tests. The results demonstrate that the device satisfies all performance and functional requirements.
Electrical Safety Testing
The LipiScan™ IVUS System complies with EN 60601-1 and EN 60601-1-2 standards as verified by independent test facilities. The LipiScan™ IVUS System software was verified and validated in accordance with applicable FDA guidance documents.
Acoustic Output Testing
Acoustic output testing for the LipiScan™ IVUS System has been performed in accordance with FDA Guidance, "Information for Manufactures Seeking Market Clearance of Diagnostic Ultrasound Systems and Transducers", issued September 30, 1997.
The InfraReDx LipiScan™ IVUS Imaging System has similar indications statements as the predicate devices. All are used for imaging of the coronary vasculature. The functionality of the InfraReDx LipiScan™ IVUS System and predicate devices is equivalent. 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
Conclusion:
Confidential
Section 5: Page 2 of 3
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K0939913 pg 3 of 3
InfraReDx LipiScan™ IVUS Imaging System
:
Premarket Notification
InfraReDx LipiScan™ IVUS Imaging System is substantially equivalent to the predicate devices.
Confidential
!
Section 5: Page 3 of 3
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread. The eagle is facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 3 0 2010
InfraReDx, Inc. C/O Steven J. Chartier Vice President, Clinical and Regulatory Affairs 34 Third Avenue Burlington, MA 01803-4414
Re: K093993
Trade/Device Name: LipiScan IVUS Imaging System Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OGZ, OBJ, IYO Dated: May 21, 2010 Received: May 24, 2010
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 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
{4}------------------------------------------------
Page 2 - Steven J. Chartier
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely your
Bram D. Zucke 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: K093993
InfraReDx LipiScan™ IVUS Imaging System Device Name:
Indications for Use:
-
- The LipiScan™ IVUS Imaging System is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography.
- a. The System is intended for the detection of lipid-core-containing plaques of interest.
- b. The System is intended for the assessment of coronary artery lipid core burden.
-
- The System is intended for ultrasound examination of coronary intravascular pathology.
- a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.
× Prescription 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 ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
W.M. Wood
vaccilar Do
510(k) Number K061399
Section 4: Page 1 of 2
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Indications for Use Table
| System: | LipiScan™ IVUS Imaging System |
|---|---|
| System Model: | MC7 |
| Transducer Model: | 40 MHz IVUS |
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Other*(Specify) | |
| Ophthalmic | Ophthalmic | ||||||||
| FetalImaging &Other | Fetal | ||||||||
| Abdominal | |||||||||
| Intra-Operative(Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify) | |||||||||
| Neonatal | |||||||||
| Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Other | |||||||||
| Cardiac | Cardiac Adult | X | |||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | X | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-Cardiac | |||||||||
| Other (Specify) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Other (Specify) |
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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).