(261 days)
The indications for use for the Accutorr Plus include the monitoring of the following human physiological vital signs:
- Blood Oxygenation (SpO2) measurement
- Temperature measurement
- Non Invasive Blood Pressure (NIBP) measurement
- Heart Rate derived from selected source (SpO2, NIBP)
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called "Accutorr Plus and Accutorr Plus with SpO2". It is a premarket notification, which means the device is being cleared for market based on its substantial equivalence to a predicate device, rather than a full premarket approval. Therefore, the document does not contain the detailed study information typically found in a Premarket Approval (PMA) application or other regulatory submission that would describe the acceptance criteria and the studies proving the device meets them.
The information requested regarding acceptance criteria and detailed study data is usually part of the submission package that led to this clearance, but it is not explicitly present in the provided FDA clearance letter and its attached "Indications for Use Statement". This letter is the result of the FDA's review of that submission, stating that the device is cleared because it was found substantially equivalent.
However, I can extract the stated indications for use, which implicitly define what the device is intended to measure. The performance metrics to prove these measurements are accurate would have been part of the 510(k) submission.
Regarding the specific questions, based only on the provided text, most of the information is not available.
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the provided text. The device is cleared for monitoring specific vital signs. Acceptance criteria would typically involve accuracy, precision, and resolution targets for these measurements (e.g., "SpO2 accuracy within +/- 2% over a range of 70-100%"). This information would have been in the original 510(k) submission.
- Reported Device Performance: Not explicitly stated in the provided text. The text only indicates the device's intended functions.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not available in the provided text.
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 available in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not available in the provided text.
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
- Not applicable/Not available. This device is a vital signs monitor, not typically an AI-assisted diagnostic imaging device that would involve human readers interpreting cases. Therefore, an MRMC study in this context is unlikely, and no information is provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This device is a standalone monitor. Its primary function is to measure and display physiological vital signs directly. The "standalone" performance is its expected performance. However, the exact methodology and results of such performance testing are not detailed in the provided clearance letter.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For vital signs monitors, ground truth typically involves comparison to a reference standard device (e.g., laboratory oximeter for SpO2, invasive arterial line for NIBP, EKG for heart rate) or direct physiological measurements. The specific methods are not detailed in this document.
8. The sample size for the training set
- Not applicable/Not available. As a vital signs monitor from 1997, it's highly unlikely it employed machine learning or AI models requiring "training sets" in the modern sense. Its operation would be based on established physiological algorithms and signal processing, not data-driven learning.
9. How the ground truth for the training set was established
- Not applicable/Not available for the reasons stated above.
Summary of what can be inferred from the provided document:
- Device Name: Accutorr Plus and Accutorr Plus with SpO2
- Regulatory Class: II
- Product Code: 74 DQA
- Indications for Use (Implicit Acceptance Criteria - what the device is intended to do):
- Monitor Blood Oxygenation (SpO2) measurement
- Temperature measurement
- Non Invasive Blood Pressure (NIBP) measurement
- Heart Rate derived from selected source (SpO2, NIBP)
- Target Populations: Adult and pediatric populations.
- Intended Use Setting: Health care facility.
- Study Proving Acceptance Criteria: The device was deemed "substantially equivalent" to a predicate device marketed before May 28, 1976. This means the manufacturer submitted data (likely including performance testing against standards) to demonstrate that the Accutorr Plus performs as safely and effectively as a legally marketed predicate device for its intended use. The details of these studies are not in this letter.
- Type of Ground Truth: For vital signs monitors, this would typically involve comparison to established reference measurement methods.
- Data Provenance (Implied): The company, Datascope Corp., is located in Paramus, New Jersey, suggesting the development and testing would likely have occurred in the US or under US regulatory guidance. The letter does not specify if the data was retrospective or prospective, or from specific countries.
In conclusion, this FDA clearance letter confirms the device is allowed to be marketed but does not provide the detailed technical study data requested. Such data would be found in the original 510(k) submission package, which is generally not publicly released in its entirety.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 25
Mr. Frank J. Casamassina Datascope Corp. Patient Monitoring Division 580 Winters Avenue Paramus, New Jersey 07652
Re: K970061 Accutorr Plus and Accutorr Plus with Sp02 Requlatory Class: II (two) Product Code: 74 DQA Dated: Auqust 29, 1997 Received: September 3, 1997
Dear Mr. Casamassina:
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 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 requlations 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 Druq 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 have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
Image /page/0/Picture/9 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure with three overlapping profiles, representing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the figure.
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Page 2 - Mr. Frank J. Casamassina
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) 594-4648. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callehan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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0178371986 - 171 45 이 대한민들 1917年12月
Indications for Use Statement
The indications for use for the Accutorr Plus include the monitoring of the following human physiological vital signs:
- Blood Oxygenation (SpO2) measurement 0
- O Temperature measurement
- ಂ Non Invasive Blood Pressure (NIBP) measurement
- Heart Rate derived from selected source (SpO2, NIBP) O
The target populations are the adult and pediatric populations. The monitor is intended for use within the health care facility setting.
Ar. A. Cizle.
(Division Sign-Off) (Division Sign-Oit)
Division of Cardiovascular, Respiratory, and Neurological Devices K970061 510(k) Number ________________________________________________________________________________________________________________________________________________________________
PRESCRIPTION USE
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).