(286 days)
The Sentinelle Endo Coil Array is a receive-only MRI coil array which must be used by a qualified medical professional to obtain images of (including spectroscopy images) the prostate, cervix and colon and the surrounding tissues in the pelvis. The Coil Array is a reusable transrectal or transvaginal device that can be high level disinfected. This product is for exclusive use on adult populations with clinically present anus and rectum or vagina. For use with GE, Toshiba and Siemens 1.5T MR systems.
The Endo Coil Array is a reusable, rigid transrectal or transvaginal receive-only MRI coil array similar to other products. The Coil Array housing has a cylindrical shape similar to transrectal and transvaginal ultrasound probes.
The Coil Array is held by an articulating Stabilization Arm that is attached to a Patient Support. The Patient Support is available in both Transporter and Tabletop versions, which dock to the scanner or are placed on top of the scanner's existing couch respectively.
The provided document is a 510(k) summary for the Sentinelle Endo Coil Array for Pelvic Imaging. It describes the device, its intended use, and provides a comparison to predicate devices, but does not include detailed performance study data such as acceptance criteria, specific reported device performance metrics, sample sizes, expert qualifications, or details about standalone/MRMC studies.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document states "Non-clinical performance testing was done to ensure the device performed equivalently to predicates in the areas of SNR comparison, spectroscopy, and image uniformity per NEMA 9:2008 with no additional concerns of safety or effectiveness." However, it does not specify explicit acceptance criteria (e.g., minimum SNR ratio, uniformity percentage) or the quantitative reported performance values of the device against these criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document mentions "Non-clinical performance testing," which typically refers to bench testing rather than clinical study data. It does not provide any information about a "test set" in terms of subject or image samples, nor their provenance.
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)
- Cannot be provided. No information regarding experts or ground truth establishment for a test set is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. No information regarding adjudication methods for a test set is mentioned.
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
- No, an MRMC study was not done. This device is an MRI coil array, not an AI-powered diagnostic tool, so an MRMC study related to AI assistance would not be applicable. The performance testing described is for the coil's physical imaging characteristics.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable in the context of an "algorithm." As this is an MRI coil, "standalone performance" refers to the coil's physical imaging capabilities in isolation from a human interpreter, which is what the non-clinical performance testing (SNR, spectroscopy, image uniformity) would assess. However, specific results are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. No information regarding ground truth used for any testing is mentioned.
8. The sample size for the training set
- Cannot be provided. No information about a "training set" is mentioned as this is not an AI/algorithmic device in the traditional sense that requires training data.
9. How the ground truth for the training set was established
- Cannot be provided. No information about a "training set" or its ground truth establishment is mentioned.
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Image /page/0/Picture/0 description: The image shows the logo for Sentinelle Medical. The logo consists of a geometric shape on the left and the words "sentinelle MEDICAL" on the right. The geometric shape is made up of lines and curves, and it resembles a stylized flower or star. The word "sentinelle" is in a smaller font than the word "MEDICAL".
AUG 18 2011
555 Richmond Street West
Suite 800, P.O. Box 301
oronto, Ontario, Canada, M5V 3B1
phone - 416-366-4994
fax - 416-594-9696
sentinellemedical.com
510(k) Summary
| Submitter: | Sentinelle Medical Inc. |
|---|---|
| Address: | 555 Richmond Street West, Suite 800Toronto, Ontario, M5V 3B1Canada |
| Contact: | Cameron Piron |
| Telephone: | 647-258-3601 |
| Date: | August 17th, 2011 |
| Trade Names: | Sentinelle Endo Coil Array for Pelvic Imaging |
| Common Names: | Sentinelle Pelvic Solution, eArray, Prostate Coil Array, Female Pelvic Coil Array |
| Classification Name: | Accessory to Magnetic Resonance Diagnostic Device,Class II as described in 21 CFR 892.1000 |
| Product Code: | MOS |
| Predicate Devices: | K053042 - MEDRAD 1.5T Pelvic Imaging System Interface Device |
Device Description:
The Endo Coil Array is a reusable, rigid transrectal or transvaginal receive-only MRI coil array similar to other products. The Coil Array housing has a cylindrical shape similar to transrectal and transvaginal ultrasound probes.
The Coil Array is held by an articulating Stabilization Arm that is attached to a Patient Support. The Patient Support is available in both Transporter and Tabletop versions, which dock to the scanner or are placed on top of the scanner's existing couch respectively.
Intended Use:
The Endo Coil Array is a receive-only MRI coil array for imaging (including spectroscopy) in the prostate, cervix and colon and surrounding pelvic tissues in adult populations with clinically present anus and rectum or vagina. The Endo Coil Array can be used with many commercial MRI scanners. This device is for exclusive use by a qualified medical professional under the order of a physician. For use with GE, Toshiba and Siemens 1.5T MR systems.
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Image /page/1/Picture/0 description: The image shows the logo for Sentinelle Medical. The logo consists of a geometric shape on the left and the words "sentinelle MEDICAL" on the right. The geometric shape is made up of lines that form a symmetrical design. The word "sentinelle" is in a larger font than the word "MEDICAL".
555 Richmond Street West
Suite 800, P.O. Box 301
Toronto, Ontario, Canada, M5V 3B1
phone - 416-366-4994
fax - 416-594-9696
sentinellemedical.com
Indications for Use:
The Sentinelle Endo Coil Array is a receive-only MRI coil array which must be used by a qualified medical professional to obtain images of (including spectroscopy images) the prostate, cervix and colon and the surrounding tissues in the pelvis. The Coil Array is a reusable transrectal or transvaginal device that can be high level disinfected. This product is for exclusive use on adult populations with clinically present anus and rectum or vagina. For use with GE, Toshiba and Siemens 1.5T MR systems.
Substantial Equivalence Summary:
| Proposed Device | Predicate Device | Substantially Equivalent Aspect |
|---|---|---|
| Endo Coil Array | MEDRAD InterfaceDevice | • Transrectal receive-only MRI coils forimaging.• Regions of interest: Prostate, Colon,Cervix and surrounding tissue.• For use exclusively by trained medicalprofessionals. |
Performance Testing:
Non-clinical performance testing was done to ensure the device performed equivalently to predicates in the areas of SNR comparison, spectroscopy, and image uniformity per NEMA 9:2008 with no additional concerns of safety or effectiveness.
Comparison to Predicate:
In the opinion of Sentinelle, the intended use and technological characteristics of the Sentinelle Endo Coil Array are substantially equivalent to those of the predicate devices and do not pose any issues for its safety and effectiveness.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes forming its body and wing. The eagle faces right and is positioned to the right of the text. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the left side of the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Sentinelle Medical. Inc. c/o Casev Conrv Senior Project Engineer Underwriters Laboratories, Inc. 1285 Walt Whitman Road MELVILLE NY 11747
AUG 1 8 2011
Re: K103274
Trade Name: Sentinelle Endo Coil Array for Pelvic Imaging Regulation Number: 21 CFR. 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: March 25, 2011 Received: July 26, 2011
Dear Mr. Conry:
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 class II (Special Controls). it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh/industry/support/index.html.
Sincerely Yours.
Mary S Postel
Mary Pastel, ScD. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K103274
Device Name: Sentinelle Endo Coil Array for Pelvic Imaging
Indications for Use:
The Sentinelle Endo Coil Array is a receive-only MRI coil array which must be used by a qualified medical professional to obtain images of (including spectroscopy images) the prostate, cervix and colon and the surrounding tissues in the pelvis. The Coil Array is a reusable transrectal or transvaginal device that can be high level disinfected. This product is for exclusive use on adult populations with clinically present anus and rectum or vagina. For use with GE, Toshiba and Siemens 1.5T MR systems
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
AND/OR
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary Petty
Division Sign Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K103274
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§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.