(49 days)
Not Found
Not Found
No
The summary describes a vaporizer and its testing against a standard, with no mention of AI or ML.
No
Explanation: The information provided describes "Penlon PPV Vaporizers" which are used in conjunction with anesthetic delivery. While essential for medical procedures, vaporizers themselves are not directly therapeutic devices that treat a disease or condition; they are drug delivery devices. The compliance with ASTM F1161:1988 also points to standards for anesthetic gas administration equipment rather than therapeutic devices.
No
Explanation: The device description states "Penlon PPV Vaporizers," which are typically used for delivering anesthetic gases and are not considered diagnostic devices. The performance studies also refer to compliance with ASTM F1161:1988 Clause 12, which relates to vaporizers for anesthetic use, further indicating it's not a diagnostic tool.
No
The device description explicitly states "Penlon PPV Vaporizers," which are hardware devices used in anesthesia. The performance studies also refer to testing of "sample vaporizers" according to a hardware standard (ASTM F1161). There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use / Indications for Use: This crucial section for identifying an IVD is "Not Found". IVDs are specifically intended for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: "Penlon PPV Vaporizers" describes a device used to deliver anesthetic vapor, which is not a typical function of an IVD.
- Performance Studies: The performance studies mentioned relate to compliance with ASTM F1161:1988, which is a standard for anesthetic vaporizers, not IVD devices. The tests described (related to external influences and compliance with this standard) are consistent with the testing of medical devices used in anesthesia.
Therefore, based on the available information, the Penlon PPV Vaporizer is a medical device used in anesthesia, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Not Found
Product codes
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Device Description
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Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5880 Anesthetic vaporizer.
(a)
Identification. An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient.(b)
Classification. Class II (performance standards).
0
Your Ref:
Our Ref:
Image /page/0/Picture/2 description: The image shows the text "ATTACHMENT 5". The text is in a large, bold font and is underlined. The word "ATTACHMENT" is in all capital letters, and the number "5" is also in a large font.
Image /page/0/Picture/3 description: The image shows the logo for Penlon InterMed. The logo consists of the word "Penlon" in a large, bold font, with the words "Inter Med" inside of a black diamond shape to the left of the word "Penlon". Below the logo is the number "K960944" written in a handwritten style.
APR - 2 1550
Penlon Limited Radley Road Abingdon
Oxon OX14 3PH Telephone: Abingdon (01235) 554222 Fax: (01235) 555252 Sales Fax: (01235) 555900 Telex Agency: 826715 AERO G Cables: Penlon Abingdon
SUMMARY OF SAFETY AND EFFECTIVENE
This 510(K) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990, and in connection with our supplement in respect of the Penlon PPV Vaporizers.
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- Compliance With Standards
We confirm that sample vaporizers have been subjected to the tests listed in ASTM F1161:1988 Clause 12, and have been shown to comply with this standard. We also confirm that the test equipment and test conditions used complied with Clause 4 of this standard.
- Compliance With Standards
The User Manual has been examined and contains the information required by the above standard.
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- An appendix to the hazard analysis has been performed on the design, based on study of literature and evaluation reports, together with in-house experience covering more than 30 years' manufacture and marketing of vaporizers.
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- The test work to show compliance with ASTM F1161:1988 Clause 12 has been extended to cover the external influences noted during the hazard analysis appendix and the results are incorporated as WARNINGS, Caution or Information in the User Manual
- (a) Vaporizer filling instructions clarification 12.1.13
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- Incorrect and overfilling protection is provided by the combination of (a) an air lock; (b) agent specific fillers; (c) level indicator with visual indication; (d) an overspill passage open during filling.
Registered Office: Silvertown House Vincent Square
1
Attachment 5 cont'd
We certify that this summary only includes information which is included in the 510(K)
supplement submission supplement submission.
for PENLON LIMITED
Avan leven
Alan C Green Technical Director