(41 days)
The intended use of the COMPACT DIGITAL CARDIAC CAMERA is to detect the location and distribution of gammu ray emitting radionuctides in the body und store data for analysis. This device includes accessories such as signal analysis and display equipment, patient and equipment supports, rudionuclide unatomical markers, component parts and accessories.
To detect or image the distribution of radionuclides in the baly or organ using the following technique(s).
(a) Planar Imaging: YES, 50-250 keV
(b) Whole Body Imaging: NO
(c) Tomographic Imaging (SPECT) for non Positron emitter: YES, 50-250 keV
(d) Positron imaging by coincidence: NO
(e) Positron imaging without coincidence: NO
(f) Other indication(s) in the device label, but not included in the above list: None
The COMPACT DIGITAL CARDIAC CAMERA nuclear imaging system has two rectangular fields of view detector heads.
The provided text describes a 510(k) premarket notification for a medical device called the "Compact Digital Cardiac Camera" (CDCC). However, it does not contain the detailed study information, acceptance criteria, sample sizes, expert qualifications, or ground truth establishment methods typically associated with proving a device meets acceptance criteria.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Bi90 Digital Cardiac Camera) rather than conducting new performance studies to establish standalone acceptance criteria.
Therefore, many of the requested fields cannot be directly extracted from the provided text. I will fill in what can be inferred or explicitly stated, and note where information is missing.
Here's the breakdown based on the provided text:
Acceptance Criteria and Device Performance Study Information
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | The intended use and features of the Compact Digital Cardiac Camera must be substantially equivalent to the predicate device (Bi90 Digital Cardiac Camera), raising no new safety or effectiveness concerns. This includes having the same range of studies, identical hardware and software for detector heads, optimized for minimal room space, and the same range of automatic clinical motions. | The document concludes that the COMPACT DIGITAL CARDIAC CAMERA is substantially equivalent to the predicate device (Bi90 Digital Cardiac Camera). It states: "The intended use of the COMPACT DIGITAL CARDIAC CAMERA is the same range of studies to that of the Bi90 Digital Cardiac Camera. The detector heads are identical in hardware and software. The ganny of the COMPACT DIGITAL CARDIAC CAMERA is optimized for minimal room space and has the same range of automatic clinical motions of the Bi90 Digital Cardiac Camera." |
| Safety and Effectiveness | The device must be deemed safe and effective and certified to the same electrical safety standards as the predicate device by a third-party organization prior to use on patients. | "The COMPACT DIGITAL CARDIAC CAMERA has been deemed safe and effective and is certified to the same electrical safety standards as the predicule device by a third party organization prior to use on patients." |
| Intended Use Compatibility | Ability to detect the location and distribution of gamma ray emitting radionuclides in the body and store data for analysis. This includes accessories like signal analysis/display, patient/equipment supports, and radionuclide anatomical markers. It supports Planar Imaging (50-250 keV) and Tomographic Imaging (SPECT) for non-Positron emitters (50-250 keV). | The device's "Indications for Use" statement confirms these capabilities: "The intended use of the COMPACT DIGITAL CARDIAC CAMERA is to detect the location and distribution of gamma ray emitting radionuctides in the body und store data for analysis." It explicitly lists Planar Imaging (✓) for 50-250 keV and Tomographic Imaging (SPECT) (✓) for 50-250 keV. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided. This 510(k) relies on substantial equivalence to a predicate device, not on new clinical performance data from a test set. There is no mention of a test set, data provenance, or study type (retrospective/prospective) for this device.
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)
- Not Applicable / Not Provided. No test set or ground truth establishment process is described for the CDCC. The "ground truth" for this submission is the established performance and safety profile of the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided. No test set or adjudication process is described.
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. This device is a gamma camera, a hardware imaging system, not an AI-assisted diagnostic software. No MRMC study or AI component is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Provided. This is a hardware device; the concept of an "algorithm only" performance study in the context of AI does not directly apply here. Its performance is demonstrated through its hardware capabilities and comparison to the predicate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Substantial Equivalence to a Predicate Device. The "ground truth" for this 510(k) is the regulatory acceptance and established performance/safety profile of the legally marketed predicate device, the Bi90 Digital Cardiac Camera. The submission asserts that the CDCC's features, intended use, and safety standards match or are equivalent to this predicate, thus implying similar performance.
8. The sample size for the training set
- Not Applicable / Not Provided. No training set is mentioned as this is a hardware device submission focused on substantial equivalence, not a machine learning algorithm.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided. (See point 8)
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501(k) SUMMARY
NOV 1 2 2003 SUBMITTERS IDENTIFICATION IS2 Medical Systems Inc. Applicant's Name and Street Address: 20 Gurdwara Rd., Units 3-10 Ottawa, Ontario, Cunada K2E 883 Victor Woodburn, Manager Quality and Regulatory Contact Person: T- (613) 228-8755. F (613) 228-8228 Telephone and Fax Number of Contact Person: Same as Applicant's Address noted above Address of Manufacturing Site: September 30, 20113 Date of Submission: DEVICE NAME Gamma Camera Device Name (Common): Compact Digital Cardiac Camera, (CDCCC) Proprietary Name: Emission Computed Tomography System Classification Name: 90-KPS Product Code: 21CFR 892.1200 CFR: l l Device Class: Bi90 Digital Cardiac Camera Predicate Device K003882 510(k) No .: (Predicate)
INTRODUCTION
This 510fk) Premarket Notification has been prepared to demonstrate that the Compuct Digital Cardiac Camera, manufactured by 152 Medical Systems Inc., is substantially equivalent to the Bi90 Digital Cardiac Camera which has previously been through the 510(k) premarket notification process. The COMPACT DIGITAL CARDIAC CAMERA nuclear imaging system has two rectangular fields of view detector heads.
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501(k) SUMMARY
INTENDED USE
The intended use of the COMPACT DIGITAL CARDIAC CAMERA is to detect the location and distribution of gamma ray emitting rudionuclides in the body and store data for analysis. This device includes accessories such as signal analysis and display equipment supports, rudionwelide anatomicul markers, component parts and accessories
DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The intended use of the COMPACT DIGITAL CARDIAC CAMERA is the sume range of studies to that of the Bi90 Digital Cardiae Camera. The detector heads are identical in hardware and software. The ganny of the COMPACT DIGITAL CARDIAC CAMERA is optimized for minimal room space und has the same range of automatic clinical motions of the Bi90 Digital Curdiac Camera.
The COMPACT DIGITAL CARDIAC CAMERA has been deemed safe and effective and is certified to the same electrical sufery standards as the predicule device by a third party organization prior to use on patients. A mutrix was constructed comparing the features and intended use of the CQMPACT DIGITAL CARDIAC CAMERA with the predicate device. We conclude that the COMPACT DIGITAL CARDIAC CAMERA is substantially equivalent to the predicate device and that no new sufety or effectiveness concerns are raised
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human figures, represented by flowing lines, suggesting a sense of unity and support.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 2 2003
Mr. Victor Woodburn Manager, Quality and Regulatory IS2 Medical Systems. Inc. Medical Diagnostics Imaging 20 Gurdwara Road, # 3 - 10 Ottawa, Ontario, K2E 8B3 CANADA
Re: K033199 Trade/Device Name: Compact Digital Cardiac Camera (CDCC) Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: 90 KPS Dated: September 30, 2003 Received: October 2, 2003
Dear Mr. Woodburn:
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.
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.
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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 Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97) you may obtain. 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,
Nancy C. Brogdon
Nancv C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
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Indications for Use Statement
510(k) Number (K033199)
Device Name COMPACT DIGITAL CARDIAC CAMERA
Indications for Use: The intended use of the COMPACT DIGITAL CARDIAC CAMERA is to detect the location and distribution of gammu ray emitting radionuctides in the body und store data for analysis. This device includes accessories such as signal analysis and display equipment, patient and equipment supports, rudionuclide unatomical markers, component parts and accessories.
To detect or image the distribution of radionuclides in the baly or organ using the following technique(s).
| (a) Planar Imaging | YES | NO | Energy Range (keV) | |
|---|---|---|---|---|
| ✓ | ✓ | 50-250 keV | ||
| (b) Whole Body Imaging | ✓ | |||
| (c) Tomographic Imaging (SPECT) for non Positron emitter | YES | NO | ||
| ✓ | 50-250 keV | |||
| (d) Positron imaging by coincidence | YES | NO | ||
| ✓ | ||||
| (e) Positron imaging without coincidence | YES | NO | ||
| ✓ | ||||
| (f) Other indication(s) in the device label, but not included in the above list | None |
PLEASE DO NOT WRITE BELOW TIMS I.INE - CONTINUE ON ANOTHER PAGE IF NEWDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancyc Brogdon
(Division Sign-C4
Division of Repr
Division of and Radiological 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
✓
Over-The-Counter Use
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.