(148 days)
Gentle heating of all transfusions and infusions close to the patient -Warm return blood flow
Astotherm Plus, Astotubes, Astoline
I am sorry, but the provided text from the FDA 510(k) notification for the "Astotherm Plus, Astotubes, Astoline" devices does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance.
The document is a general clearance letter stating that the device is "substantially equivalent" to previously marketed devices and lists its "Indications for Use." It does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number or qualifications of experts for ground truth.
- Adjudication method.
- Information on any multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
- Details about a standalone (algorithm only) performance study.
- Type of ground truth used (e.g., pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
This type of information would typically be found in detailed premarket submission documents, clinical trial reports, or performance testing summaries, which are not present in this specific clearance letter.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP -2 1999
Stihler Electronic GMBH C/O Mr. Richard C. Lanzillotto North American Technical Services Corporation 30 Northport Road Sound Beach, New York 11789-1734
Re : K991160 Astotherm Plus, Astotubes, Astoline Trade Name: Requlatory Class: II Product Code: BSB Dated: June 3, 1999 Received: June 9, 1999
Dear Mr. Lanzillotto:
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 The general controls provisions of the Act 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory 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
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Page 2 - Mr. Lanzillotto
This letter will allow you to begin marketing your device as first ited in your 510(k) premarket notification. The FDA described in your six (i) provivalence of your device to a legally Finding or bubboardains in a classification for your marketed predicate actros 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 regaradiagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on compriation and advertising of your device, please contact che office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
the regulation entitled, "Misbranding by reference to information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance obeathed from onemen (800) 638-2041 or (301) 443-6597 or at at Ics Coll Free namble (o://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Diredtor Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Stihler Electronic GMBH Astotherm Plus
Page 4
Abbreviated 510K 03/25/99
な
:
INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
Astotherm Plus, Astotubes, Astoline
Indications for Use:
Gentle heating of all transfusions and infusions close to the patient
-Warm return blood flow
Contraindications: Warnings and Precautions
See Attached
Pulacia Accente
(Dision Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
escription Use
'er 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
§ 864.9205 Blood and plasma warming device.
(a)
Nonelectromagnetic blood or plasma warming device —(1)Identification. A nonelectromagnetic blood and plasma warming device is a device that warms blood or plasma, by means other than electromagnetic radiation, prior to administration.(2)
Classification. Class II (performance standards).(b)
Electromagnetic blood and plasma warming device —(1)Identification. An electromagnetic blood and plasma warming device is a device that employs electromagnetic radiation (radiowaves or microwaves) to warm a bag or bottle of blood or plasma prior to administration.(2)
Classfication. Class III (premarket approval).(c)
Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval for the device described in paragraph (b)(1). See § 864.3.