(134 days)
No
The document describes a software-controlled ventilator but makes no mention of AI, ML, or related concepts.
Yes
The device is described as providing continuous mechanical ventilatory support, which is a therapeutic intervention for patients undergoing general anesthesia.
No
Explanation: The device is described as an "Anaesthesia Ventilator" intended to provide "continuous mechanical ventilatory support." While it can "monitor anaesthetised patients" in spontaneous mode, its primary function is ventilation, not diagnosis.
No
The device description explicitly mentions hardware components such as a "ventilator control unit," a "remote display screen unit," a "swivel mounting arm," and an "interconnecting cable." While the device is software-controlled, it is not solely software.
Based on the provided information, the AV-S Anaesthesia Ventilator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide mechanical ventilatory support during general anaesthesia. This is a life-support function performed directly on the patient.
- Device Description: The device description focuses on its function as a ventilator for breathing support and monitoring of anaesthetized patients.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed to perform tests on biological samples outside of the body. The AV-S Anaesthesia Ventilator operates on the patient to assist with breathing.
N/A
Intended Use / Indications for Use
The AV-S Anaesthesia Ventilator is intended to provide continuous mechanical ventilatory support during general anaesthesia. The ventilator is a restricted medical device intended for use by qualified trained personnel, i.e. Nurses and Anaesthesia Technicians under the direction of a Physician. Specifically the ventilator is indicated for use by both adult and pediatric patients.
The AV-S Anaesthesia ventilator is a prescription device and the labelling indicates this.
Product codes
CBK
Device Description
The AV-S Ventilator is a software controlled multi-mode ventilator designed for mechanical ventilation of adult and paediatric patients under general anaesthesia for more than one hour. In addition, in spontaneous mode, it can be used to monitor spontaneous breathing of anaesthetised patients. It is designed for use in closed circuit anaesthesia and also to drive a Mapleson D circuit.
The AV-S Ventilator is also available with a remote display screen unit that can be affixed to an anaesthesia machine and be located remotely from the ventilator control unit. The display screen is affixed to the anaesthesia ventilator by a swivel mounting arm. An interconnecting cable is provided to transmit data between the control unit and the remote display screen unit.
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
adult and paediatric patients
Intended User / Care Setting
qualified trained personnel, i.e. Nurses and Anaesthesia Technicians under the direction of a Physician.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K010317, K010318, K960964, K023366
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).
0
SEP 2 3 2005
Section G
AV-S Anaesthesia Ventilator 510(k) No. K051222 Supplement
Candidate Device 510(k) Summary of Safety and Effectiveness Information
The following information is furnished in accordance with 21 CFR 807.92(a):
Submitter's name and address: 1.
Penlon Limited Unit A Barton Mill Audlett Drive Abingdon Oxfordshire OX14 3NJ United Kingdom
- Submitter's telephone number and fax number: 2.
- Tel. 001 44 1235 547000 Fax: 001 44 1235 547041
-
- Contact person: Mr. Anthony Parsons - Quality Manager
- Date this 510(k) summary prepared: 4. May 4, 2005
- Trade/proprietary name of the device: 5. AV-S Anaesthesia Ventilator
- Classification name and number of the device: 6. Continuous Ventilator 21CFR 868.5895
- Legally marketed predicate devices to which substantial equivalence 7. · is claimed:
-
- Penlon Limited AV800 Anaesthesia Ventilator FDA 510(k) No. K010317 approved by FDA on July 23, 2001. FDA Device Classification: Class II FDA Classification Number: 21CFR 868.5895 FDA Classification Code: CBK
-
- Penlon Limited Prima Oxygen Monitor FDA 510(k) No. K010318 approved by FDA on July 23, 2001 FDA Device Classification: Class II FDA Classification Number: 21CFR 868.1720 FDA Classification Code: CCL
- PDA Sidocinoa.com . 7900 Anaesthesia Ventilator FDA 510(k) No. ကံ K960964 approved by FDA on September 27, 1996, and K023366 approved by FDA on October 7, 2003 FDA Device Classification: Class II FDA Classification Number: 21CFR 868.5895 FDA Classification Code: CBK
-
AV-S510ksuppsecG
Section G Page 1 of 2
1
Section G
AV-S Anaesthesia Ventilator 510(k) No. K051222 Supplement
Description of the device that is the subject of this premarket 8. notification:
The AV-S Ventilator is a software controlled multi-mode ventilator designed f r mechanical ventilation of adult and paediatric patients under general for moonahour verkliion, in spontaneous mode, it can be used to monitor anacsthoold. In adallion, patients. It is designed for use in closed circuit anaesthesia and also to drive a Mapleson D circuit.
510(k) Supplement additional information:
The AV-S Ventilator is also available with a remote display screen unit that can be affixed to an anaesthesia machine and be located remotely from the ventilator control unit. The display screen is affixed to the anaesthesia vonthator of a swivel mounting arm. An interconnecting cable is provided to transmit data between the control unit and the remote display screen unit.
Intended use and indication for use: 9.
The AV-S Anaesthesia Ventilator is intended to provide continuous mechanical ventilatory support during general anaesthesia. The ventilator is a restricted medical device intended for use by qualified trained is a Testholou Throusand Technicians under the direction of a Physician. Specifically the ventilator is applicable for adult and pediatric patients.
The AV-S Anaesthesia ventilator is a prescription device and the labeling indicates this.
Technological characteristics: 10.
The technological characteristics of the AV-S and the predicate devices, the Penlon AV 800 and the Datex-Ohmeda 7900 (also known as SmartVent), are very similar in that they are all software controlled Smartvent), are very of millar indications for use of all three devices are the same.
The main technological difference is that the AV-S incorporates the The main toolihologican Prima Oxygen monitor, an approved device technology of the Porketed separately, and some additional software that that was for three advanced spontaneous breathing support modes.
This concludes the 510(k) summary.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and head. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" written around the circumference of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 3 2005
Penlon Limited C/O Mr. Barry Pearce Shotwell & Carr, Incorporated 25 Barker, Close Fishbourne, Chichester West Sussex, UNITED KINGDOM P018 8BJ
Re: K051222
K051222
Trade/Device Name: AV-S ANAESTHESIA VENTILATOR Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous ventilator Regulatory Class: II Product Code: CBK Dated: September 1, 2005 Received: September 19, 2005
Dear Mr. Pearce:
We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your bection by (1) +) + cevice is substantially equivalent (for the referenced above and have determined and as needly marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device interstate comments, or to devices that have been reclassified in accordance with the provisions of Allentifielis, of to devices mat nave o ot (Act) that do not require approval of a premarket the Federal Pood, Drug, und Ocomers , therefore, market the device, subject to the general approval approvisions of the Act. The general controls provisions of the Act include controls provisions of the rica - The girling 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 if your device is classified (see above) into examples Existing major regulations affecting (PMA), it may of subject to sach adams may rate the rate the 21, Parts 800 to 898. In your device can be found in the South in the Soucerning your device in the Federal Register.
3
Page 2 - Mr. Pearce
Please be advised that FDA's issuance of a substantial equivalence determination does not
ement Please be advised that FDA's Issuantal equires with other requirements
mean that FDA has made a determination that your devices with other Federal agencies, mean that FDA has made a determination hat our administered by other Federal agencies.
of the Act or any Federal statutes and regulations administers to: registration of the Act or any Federal statues and reginations and limited to: registration
You must comply with all the Act 's requirements, including, but not limited to: registration You must comply with all the Act S requirements interesting
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 807); labelling (21 CFR Part 807); Books (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) requirements as set forth in the quality systems (QS) regulation (Sections 531-542 of the Act);
applicable, the electronic product radiation control provisions (Sections 531-21 CFR 1000-1050.
21 CFR 1000-1050.
This letter will allow you to begin marketing your device of your device to a This letter will allow you to begin matic.cling of substantial equivalence of your device to a
premarket notification. The FDA finding of substantial equivalence and thus, p premarket notification. The FDA linding of substantial equired. Posts on 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),
Ales, Alas, Alaman, Career, Cara, Cara, Aleo, Aleg, Aleg, Aleg, Aleg, Alegse note If you desire specific advice for your device of (24) 276-0120. Also, please note the regulation
please contact the Office of Compliance at (240) 276-0120. Also, please not please contact the Unice of Compilance at (210) 276 occion's (21CFR Part 807.97). You
entitled, "Misbranding by reference to premarket notification woder the Act from the entitled, "Misbranding by relefence to premails"). " (e. may obtain other general miornation on your espectational and Consumer Assistance at its toll-free
Division of Small Manufacturers, International and Consumer Assistance at i Division of Sman Manafactarers, 23-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Device Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name:
AV-S Anaesthesia Ventilator
Indications For Use:
The AV-S Anaesthesia Ventilator is intended to provide continuous mechanical ventilatory The AV-S Anaesthesia Ventilator is Intended is a restricted medical device intended support during general anaesthesia. The Ventisians under the direction of a
for use by qualified trained personnel, i.e. Nurses and heath one nediation atients for use by qualified trained persomer, i.e. Nurses and Toombile and pediatric patients.
Physician. Specifically the ventilator is indicated for use by both adult and pediatr
The AV-S Anaesthesia ventilator is a prescription device and the labelling indicates this.
YES Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Quen Siliom
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number K05122
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