(182 days)
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No
The summary describes a standard anesthesia machine with gas delivery and ventilation components, and there is no mention of AI, ML, or related concepts.
Yes
Explanation: The device is an "anesthesia machine" used to "deliver anesthesia," which is a medical treatment.
No
This device is described as an "anesthesia machine" used to "deliver anesthesia." Its components and accessories are focused on anesthesia delivery, not on diagnosing medical conditions or diseases.
No
The device description explicitly states it is an "anesthesia machine" and includes physical components like gas delivery systems, a vaporizer, and a ventilator, indicating it is a hardware device with potentially integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states the device is an "anesthesia machine that includes the components and accessories necessary to deliver anesthesia." This is a device used on a patient to administer gases for anesthesia, not a device used to examine specimens in vitro (outside the body) to diagnose conditions.
- Device Description: The description details the components involved in delivering breathing circuit gases and powering a ventilator, all related to administering anesthesia directly to a patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on specimens, or providing diagnostic information based on in vitro analysis.
Therefore, the Ohmeda APAC System is an anesthesia delivery system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The APAC is a self-contained, portable and lightweight anesthesia machine that includes ... . the components and accessories necessary to deliver anesthesia. The APAC System delivers three breathing circuit gases: O2 (cylinder or pipeline), N2O (pipeline only), air (pipeline only). The APAC System includes a Tec 5 Vaporizer. The APAC System uses a 7800 Ventilator changed to use O2 or air as the pneumatic power source.
Safety devices decrease the risk of:
Hypoxic Mixtures: A flow control proportioning system keeps the O2 concentration higher than 23% at the fresh gas outlet for O2 and N2O mixtures. N2O flow decreases proportionally as the O2 supply decreases. N2O and air flow stops completely in case of total O2 supply failure.
Complete power or sudden gas supply failures: Batteries continue 7800 Ventilator operation during a power failure. Ohmeda ventilators have power failure alarms. Ohmeda ventilators have alarms for low gas supply pressure. The APAC System has an alarm for O2 supply pressures less than 27 to 33 psig (186 to 228 kPa).
Product codes (comma separated list FDA assigned to the subject device)
73 BSZ
Device Description
The Ohmeda APAC System is a self-contained, portable and lightweight anesthesia machine that includes the components and accessories necessary to deliver anesthesia. Gases and vaporizers; The APAC System delivers three breathing circuit gases: O₂ (cylinder or pipeline), N₂Ο (pipeline only), air (pipeline only). The APAC System includes a Tec 5 Vaporizer. Ventilators; The APAC System uses a 7800 Ventilator changed to use O2 or air as the pneumatic power source. Patient Safety; Safety devices decrease the risk of: Hypoxic Mixtures; A flow control proportioning system keeps the O2 concentration higher than 23% at the fresh gas outlet for O2 and N2O mixtures. N2O flow decreases proportionally as the O2 supply decreases. N2O and air flow stops completely in case of total 02 supply failure. Complete power or sudden gas supply failures: Batteries continue 7800 Ventilator operation during a power failure. Ohmeda ventilators have power failure alarms. Ohmeda ventilators have alarms for low gas supply pressure. The APAC System has an alarm for O2 supply pressures less than 27 to 33 psig (186 to 228 kPa).
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 868.5160 Gas machine for anesthesia or analgesia.
(a)
Gas machine for anesthesia —(1)Identification. A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply.(2)
Classification. Class II (performance standards).(b)
Gas machine for analgesia —(1)Identification. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide).(2)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the word "OHMEDA" in a bold, black font. A symbol resembling a snake is placed vertically in the middle of the word, partially obscuring the letters. The letters are large and closely spaced, creating a strong visual impact.
THE BOC GROUP
JUN 17 1997
Ohmeda Inc Ohmeda Drive PO Box 7550 Madison WI 53707-7550 608 221 1551
December 6, 1996
510(k) Summary of Safety and Effectiveness Information for the Subject: Ohmeda APAC (Advanced Portable Anesthesia Care) System Ohmeda APAC (Advanced Portable Anesthesia Care) System Proprietary: Gas Machine. Anesthesia Common: Anesthesiology, 73BSZ, 21CFR868.5160 Classification:
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 1992.
The Ohmeda APAC System is substantially equivalent to the following currently marketed device:
-
- Ohmeda Excel Series Anesthesia Machines Class II 21CFR868.5160
The APAC is a self-contained, portable and lightweight anesthesia machine that includes the components and accessories necessary to deliver anesthesia. Gases and vaporizers; The APAC System delivers three breathing circuit gases: O₂ (cylinder or pipeline), N₂Ο (pipeline only), air (pipeline only). The APAC System includes a Tec 5 Vaporizer. Ventilators; The APAC System uses a 7800 Ventilator changed to use O2 or air as the pneumatic power source. Patient Safety; Safety devices decrease the risk of: Hypoxic Mixtures; A flow control proportioning system keeps the O2 concentration higher than 23% at the fresh gas outlet for O2 and N2O mixtures. N2O flow decreases proportionally as the O2 supply decreases. N2O and air flow stops completely in case of total 02 supply failure. Complete power or sudden gas supply failures: Batteries continue 7800 Ventilator operation during a power failure. Ohmeda ventilators have power failure alarms. Ohmeda ventilators have alarms for low gas supply pressure. The APAC System has an alarm for O2 supply pressures less than 27 to 33 psig (186 to 228 kPa).
- Ohmeda Excel Series Anesthesia Machines Class II 21CFR868.5160
The Ohmeda APAC System was designed to comply with the applicable portions of the following voluntary standards:
-
- ASTM F1161-88 for the Anesthesia Machine System
-
- EN 60601-1-2, IEC 601-1-2 for the 7800 Ventilator
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- EN 60601-1, IEC 601-1 and IEC 601-2-13 for the 7800 Ventilator
-
- DIN 13252 for the Tec 5 Sevotec 8%
-
- DIN 13252 for the Tec 5 Fluotec 5%
-
- DIN 13252 for the Tec 5 Enfluratec5%
-
- DIN 13252 for the Tec 5 Isotec5%
The Ohmeda APAC System and the currently marketed devices are substantially equivalent in design concepts, technologies and materials. The Ohmeda APAC System has been validated through rigorous testing that, in part, support the compliance of the APAC to the above mentioned standards.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure with three arms or lines extending from the body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the figure in a circular pattern.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 17 1997
Mr. Chuck Morreale Ohmeda Inc. Ohmeda Drive P.O. Box 7550 Madison, Wisconsin 53707-7550
Re: *K965041 Ohmeda Advanced Portable Anesthesia Care (APAC) System Requlatory Class: II (two) Product Code: 73 BSZ Dated: March 17, 1997 March 19, 1997 Received:
Dear Mr. Morreale:
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 reqistration, listing of devices, qood 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. A 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 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.
2
Page 2 - Mr. Chuck Morreale
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): K96 دری
Device Name: Ohmeda APAC System
Indications For Use:
The APAC is a self-contained, portable and lightweight anesthesia machine that includes ... . the components and accessories necessary to deliver anesthesia. " = = = = = = = =
Gases and vaporizers
The APAC System delivers three breathing circuit gases:
- O2 (cylinder or pipeline) .
- N2O (pipeline only) ●
- air (pipeline only) .
The APAC System includes a Tec 5 Vaporizer
Ventilators
华
The APAC System uses a 7800 Ventilator changed to use O2 or air as the pneumatic power source.
Patient Safety
Safety devices decrease the risk of:
Hypoxic Mixtures
- A flow control proportioning system keeps the O2 concentration higher than 23% at the ● fresh gas outlet for O2 and N2O mixtures.
- N2O flow decreases proportionally as the O2 supply decreases.
- N2O and air flow stops completely in case of total O2 supply failure. .
Complete power or sudden gas supply failures
- Batteries continue 7800 Ventilator operation during a power failure. ●
- Ohmeda ventilators have power failure alarms. ●
- Ohmeda ventilators have alarms for low gas supply pressure. .
- The APAC System has an alarm for O2 supply pressures less than 27 to 33 psig (186 to . 228 kPa).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
f. Althoff-Kaiser
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Prescription Use
(Per 21CFR801.109)
OR
Over-The-Counter Use_ (Optional Format 1-2-96)