(137 days)
The Navigator Anesthesia Delivery System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation.
The Navigator System is intended for use by licensed clinicians, for patient requiring anesthesia within a health care facility, and can be used in both adult and pediatric populations.
The Navigator Anesthesia Delivery System is a continuous flow anesthesia system which offers manual or automatic ventilation, easily adjustable fresh gas delivery, anesthetic agent delivery, ventilation monitoring, convenient ergonomics, and state-of-the-art safety systems. The Navigator System is designed to decrease the risk of hypoxic mixtures and the inadvertent movement of the air flow control knobs. Additionally, the Navigator provides battery power in the event of an AC power outage. Multiple ventilation modes, i.e., CMV, PCV, SIMV and PSV, are offered by the Navigator System with electronic PEEP available in each of the modes. The fresh gas dosing subsystem offers features of a traditional anesthesia system along with dual flow tubes which display the gas flows at all times. The Navigator contains two vaporizers and a heated breathing system to minimize condensation and return moisture to the patient.
The provided text describes the 510(k) summary for the Navigator Anesthesia Delivery System. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study proving the device meets specific acceptance criteria with quantifiable performance metrics.
Therefore, the information required to fully answer your request (acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not provided in the given text.
Here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as specific performance thresholds. The document generally states compliance with "recognized safety, performance and electromagnetic compatibility standards."
- Reported Device Performance: Not quantified. The document states it has been "tested and found to be in compliance" with these standards.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not mentioned.
- Data Provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not applicable. The "testing" mentioned refers to compliance with engineering/safety standards, not clinical ground truth established by experts.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No, this is an anesthesia delivery system, not an AI-assisted diagnostic tool for human readers.
- Effect Size of AI: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable as it's not an algorithm, but a medical device. The "software has been validated" refers to internal software validation, not a standalone performance evaluation in the context of AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not applicable in the traditional sense of diagnostic AI. The "ground truth" for this device would be established by validated engineering tests and compliance with recognized standards.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is not an AI/machine learning device that uses a training set.
9. How the ground truth for the training set was established
- How Ground Truth was established: Not applicable.
Summary of available information regarding the "study" (Performance Testing):
The document mentions a "Summary of Performance Testing" which states:
- "The Navigator System has been tested and found to be in compliance with recognized safety, performance and electromagnetic compatibility standards."
- "A risk analysis has been developed to identify potential hazards and document the mitigation of the hazards."
- "The device's software has been validated in accordance with the requirements set forth in the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005)."
- The conclusion states that based on this performance testing, the device is "safe, effective and substantially equivalent to the predicate device."
In essence, the "study" proving the device meets acceptance criteria is a series of engineering and software validation tests demonstrated to comply with established medical device standards and FDA guidance for substantial equivalence, rather than a clinical study with detailed performance metrics, patient cohorts, or expert ground truth.
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Image /page/0/Picture/0 description: The image shows the word "Datascope" in a stylized font. Above the word is a curved line that starts thick on the left and thins out as it moves to the right, creating an arc over the word. The "®" symbol is located to the right of the word.
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Ko80175
510(k) Summary
Navigator Anesthesia Delivery System
This 510(K) Summary is provided in accordance with 21 CFR 807.92.
JUN - 9 2008
| Date: | January 23, 2008 |
|---|---|
| Submitter: | Datascope Corp.800 MacArthur Blvd.Mahwah, NJ 07430Contact: Kathleen KramerManager, Clinical and Regulatory AffairsTelephone: 201-995-8169Facsimile: 201-995-8605 |
| Device Trade Name: | Navigator Anesthesia Delivery System |
| Common Name: | Gas-Machine, Anesthesia |
| Device Classification: | Anesthesiology21 CFR 868.5160, Product code: BSZ, Class: II |
| Predicate Devices: | Modular Anesthesia System, Heyer America Inc. (K001988) andAvance Anesthesia System, GE Datex-Ohmeda (K071142). |
| Device description: | The Navigator Anesthesia Delivery System is a continuous flowanesthesia system which offers manual or automatic ventilation,easily adjustable fresh gas delivery, anesthetic agent delivery,ventilation monitoring, convenient ergonomics, and state-of-the-artsafety systems. The Navigator System is designed to decrease therisk of hypoxic mixtures and the inadvertent movement of the airflow control knobs. Additionally, the Navigator provides batterypower in the event of an AC power outage.Multiple ventilation modes, i.e., CMV, PCV, SIMV and PSV, areoffered by the Navigator System with electronic PEEP available ineach of the modes. The fresh gas dosing subsystem offers featuresof a traditional anesthesia system along with dual flow tubes whichdisplay the gas flows at all times. The Navigator contains twovaporizers and a heated breathing system to minimizecondensation and return moisture to the patient. |
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501(K) Summary
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innovation is the best medicine
| Indications for Use: | The Navigator Anesthesia Delivery System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation.The Navigator System is intended for use by licensed clinicians, for patient requiring anesthesia within a health care facility, and can be used in both adult and pediatric populations. |
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| Technological Comparison to Predicate Device: | The Navigator System is technically equivalent to Heyer America's Modular Anesthesia System (K001988) and GE Datex-Ohmeda's Avance Anesthesia System (K071142) with respect to indications for use and technical/performance characteristics. |
| Summary of Performance Testing: | The Navigator System has been tested and found to be in compliance with recognized safety, performance and electromagnetic compatibility standards.A risk analysis has been developed to identify potential hazards and document the mitigation of the hazards. The device's software has been validated in accordance with the requirements set forth in the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005). |
| Conclusion: | Based on the above description, technological comparison, performance testing and the supporting documentation it can be concluded that the Navigator Anesthesia Delivery System is safe, effective and substantially equivalent to the predicate device. |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kathleen Kramer Manager, Clinical & Regulatory Affairs Datascope Corporation Patient Monitoring Division 800 MacArthur Boulevard Mahwah, New Jersey 07430
JUN - 9 2008
Re: K080175
Trade/Device Name: Navigator Anesthesia Delivery System Regulation Number: 21 CFR 868.5160 Regulation Name: Gas Machine for Anesthesia or Analgesia Regulatory Class: II Product Code: BSZ Dated: May 16, 2008 Received: May 19, 2008
Dear Ms. Kramer:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA), 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 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Kramer
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chih-Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Navigator Anesthesia Delivery System
Indications For Use:
The Navigator Anesthesia Delivery System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation.
The Navigator is intended for use by licensed clinicians, for patients requiring anesthesia within a health care facility, and can be used in both adult and pediatric populations.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mi Khul
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of
K080 175 510(k) Number:
§ 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).