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K Number
K991160
Device Name
ASTOTHERM PLUS, ASTOTUBES, ASTOLINE
Manufacturer
STIHLER ELECTRONIC GMBH
Date Cleared
1999-09-02

(148 days)

Product Code
BSB
Regulation Number
864.9205
Type
Abbreviated
Panel
HE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Gentle heating of all transfusions and infusions close to the patient -Warm return blood flow

Device Description

Astotherm Plus, Astotubes, Astoline

AI/ML Overview

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:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance for a test set.
  3. Number or qualifications of experts for ground truth.
  4. Adjudication method.
  5. Information on any multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
  6. Details about a standalone (algorithm only) performance study.
  7. Type of ground truth used (e.g., pathology, outcomes data).
  8. Sample size for the training set.
  9. 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.

§ 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.