(121 days)
The Ambu® Oval Silicone resuscitator is intended for manual pulmonary resuscitation and emergency respiratory support.For use by CPR-trained personnel only, in hospital and pre-hospital settings.
The Ambu Oval Silicone resuscitator is reusable. The range of application for the sizes are:
Adult: Adults and children with a body weight of more than approx. 30 kg (66 lbs.). Paediatric: Infants and children with a body weight between approx. 10-30 kg (22~66 lbs.)
Ambu Oval Resuscitators is for manual pulmonary resuscitation and emergency respiratory support. Ambu Oval Resuscitators are in two sizes; Adult & Pediatric. It is a reusable product.
The product consists of a resuscitator bag, inlet valve and outlet valve. Oxygen reservoirs can be mounted to the inlet valve.
Facemask, Endotracheal Tube or similar device is connected to the resuscitator patient valve to ensure contact to the patient's airway.
The inlet valve allows ambient air with or without supplementary oxygen to flow into the bag and prevents air flowing backwards from the bag through the inlet valve during ventilation.
When the resuscitator bag is compressed air is delivered via the patient valve to the patient. The bag is made of a self-expanding material, which ensures the bag to have sufficient compression and recoiling properties.
Pressure limiting valve (40 cmH2O) with an override mechanism is placed in patient valve housing. On Pediatric resuscitators there are always a Pressure limiting valve and on Adult resuscitators there are product types available with and without Pressure limiting valve.
Ambu Ova! Resuscitator complies with ISO 10651-4: Particular requirements for operator powered resuscitators.
Ambu Oval Resuscitators have the following physical and performance characteristics:
- Provided in two sizes: Adult & Pediatric .
- -Reusable
- 22 mm (outside) / 15 mm (inside) Patient Connector -
- 30 mm Expiratory Connector -
- Resuscitator Volume: Pediatric: 635 ml Adult: 1475 ml .
- Stoke Volume one hand: Pediatric: 450 ml Adult: 700 ml ・
- Stroke Volume two hands: Pediatric: NA Adult: 1475 ml -
- Can be used with ambient air and/or supplementary oxygen.
- : Pressure Limiting Valve: 40 cmH2O / 4.0 kPa, and port for attachment of manometer
The Ambu® Oval Silicone Resuscitator's acceptance criteria and the study proving its compliance are described below. The device is a manual resuscitator for pulmonary resuscitation and emergency respiratory support, available in adult and pediatric sizes.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Ambu® Oval Silicone Resuscitator are primarily based on conformance to recognized consensus standards and performance characteristics comparable to legally marketed predicate devices.
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Regulatory Compliance | Declaration of conformity to ISO 10651-4 | Complies |
| Declaration of conformity to ISO 5356-1 | Complies | |
| Biocompatibility | Conformance to ISO 10993-1 (cytotoxicity, sensitization, intracutaneous reactivity) | Complies with requirements of ISO 10993-1 (Cytotoxicity, Sensitization, Intracutaneous reactivity tests performed) |
| Cleaning/Sterilization | Automated Cleaning Validation (per AAMI TIR 12 and TIR 30) | Data submitted demonstrated compliance |
| Steam Sterilization Validation (per AAMI TIR 12 and TIR 30) | Data submitted demonstrated compliance | |
| Physical Characteristics | Provided in two sizes | Adult & Pediatric sizes provided |
| Patient Connector (22mm outside/15mm inside) | 22 mm (outside) / 15 mm (inside) Patient Connector | |
| Expiratory Connector (30mm) | 30 mm Expiratory Connector | |
| Performance Characteristics | Resuscitator Volume | Pediatric: 635 ml; Adult: 1475 ml |
| Stroke Volume (one hand) | Pediatric: 450 ml; Adult: 700 ml | |
| Stroke Volume (two hands) | Pediatric: NA; Adult: 1475 ml | |
| Usability with ambient air and/or supplementary oxygen | Can be used with ambient air and/or supplementary oxygen | |
| Pressure Limiting Valve | 40 cmH2O / 4.0 kPa, and port for attachment of manometer | |
| Substantial Equivalence | Equivalence to listed predicate devices for intended use, operation, and technological characteristics | Concluded to be substantially equivalent to K910040, K053140 (Adult) and K914187, K053142 (Pediatric) |
2. Sample size used for the test set and the data provenance
The provided 510(k) summary does not specify the exact sample sizes used for each individual test (e.g., biocompatibility testing involved multiple tests as listed but the number of samples tested for each is not detailed). The testing falls under bench testing, meaning the data provenance is from laboratory tests of the device itself rather than patient data. Therefore, there is no information on country of origin for patient data or whether it was retrospective or prospective, as no clinical data was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the device's acceptance criteria and performance data are based on bench testing against recognized standards and comparative characteristics of predicate devices, not on expert-established ground truth from clinical cases. There were no experts involved in establishing ground truth for a "test set" in the context of clinical or diagnostic performance. Expertise would have been involved in the design and execution of the bench tests and the interpretation of results against engineering and biological safety standards, but these individuals are not described as "experts" used to establish a ground truth for a test set in the way one would for an AI diagnostic device.
4. Adjudication method for the test set
This information is not applicable as the determination of whether the device meets acceptance criteria is based on objective measurements and compliance with established standards during bench testing, not on adjudicated clinical outcomes or interpretations.
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
No MRMC comparative effectiveness study was done. The 510(k) summary explicitly states: "No clinical tests are performed." This device is a manual resuscitator, not an AI-assisted diagnostic tool, so the concept of human readers improving with or without AI assistance is irrelevant here.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a manual resuscitator, a physical medical device operated by CPR-trained personnel, not an algorithm. Therefore, "standalone algorithm performance" is not a relevant concept for this product.
7. The type of ground truth used
The "ground truth" for this device's performance is established through conformance to recognized consensus standards (ISO 10651-4, ISO 5356-1, ISO 10993-1, AAMI TIR 12, AAMI TIR 30) and the measured physical and performance characteristics of the device, which are then compared to those of legally marketed predicate devices. This is a form of benchmarking and standard compliance.
8. The sample size for the training set
Not applicable. A "training set" typically refers to data used to train machine learning models. As this is a physical medical device without AI components, there is no training set in this context.
9. How the ground truth for the training set was established
Not applicable for the reasons stated in point 8.
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510(k) Application – Ambu® Oval Silicone Resuscitator
510(k) Summary
This 510(k) summary has been prepared in accordance with 21 CFR 807.87(h) and the 510(k) has been prepared in accordance with 21 CFR 807.92
Submitter
Ambu A/S Baltorpbakken 13 DK-2750 Ballerup Denmark tel .: +45 7225 2000 fax .: +45 7225 2055
Contact Person
Name: Kaja Tengbjerg Job Title: Regulatory Affairs Professional Address: Ambu A/S, Baltorpbakken 13, DK-2750 Ballerup Telephone number: +45 7225 2215 Fax number: +45 7225 2055
Date Summary Prepared
September 21, 2010
Device Trade Name
Ambu® Oval Silicone Resuscitator, Adult Ambu® Oval Silicone Resuscitator, Pediatric
Device Common Name
Manual Resuscitator (Reusable)
Device Classification
Ventilator, Emergency, Manual Product Codes: BTM 21 CFR 868.5915 Class II
Legally Marketed devices to which the device is substantially equivalent:
Ambu Oval Resuscitator, Adult
| Manufacturer | Trade Name | 510(k) number |
|---|---|---|
| Ambu Silicone | Resuscitator, Adult | K910040 |
| Ambu | Mark IV Resuscitator, Adult | K053140 |
Ambu Oval Resuscitator, Pediatric
| Manufacturer | Trade Name | 510(k) number |
|---|---|---|
| Ambu Silicone | Resuscitator, Infant/Child | K914187 |
| Ambu | Mark IV Resuscitator, Baby | K053142 |
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Description of the Device
Ambu Oval Resuscitators is for manual pulmonary resuscitation and emergency respiratory support. Ambu Oval Resuscitators are in two sizes; Adult & Pediatric. It is a reusable product.
The product consists of a resuscitator bag, inlet valve and outlet valve. Oxygen reservoirs can be mounted to the inlet valve.
Facemask, Endotracheal Tube or similar device is connected to the resuscitator patient valve to ensure contact to the patient's airway.
The inlet valve allows ambient air with or without supplementary oxygen to flow into the bag and prevents air flowing backwards from the bag through the inlet valve during ventilation.
When the resuscitator bag is compressed air is delivered via the patient valve to the patient. The bag is made of a self-expanding material, which ensures the bag to have sufficient compression and recoiling properties.
Pressure limiting valve (40 cmH2O) with an override mechanism is placed in patient valve housing. On Pediatric resuscitators there are always a Pressure limiting valve and on Adult resuscitators there are product types available with and without Pressure limiting valve.
Ambu Ova! Resuscitator complies with ISO 10651-4: Particular requirements for operator powered resuscitators.
Ambu Oval Resuscitators have the following physical and performance characteristics:
- Provided in two sizes: Adult & Pediatric .
- -Reusable
- 22 mm (outside) / 15 mm (inside) Patient Connector -
- 30 mm Expiratory Connector -
- Resuscitator Volume: Pediatric: 635 ml Adult: 1475 ml .
- Stoke Volume one hand: Pediatric: 450 ml Adult: 700 ml ・
- Stroke Volume two hands: Pediatric: NA Adult: 1475 ml -
- Can be used with ambient air and/or supplementary oxygen.
- : Pressure Limiting Valve: 40 cmH2O / 4.0 kPa, and port for attachment of manometer
Intended use
Ambu Oval Resuscitator Adult and Pediatric:
Ambu® Oval Resuscitator is intended for manual pulmonary resuscitation and emergency respiratory support. For use by CPR-trained personnel only, in hospital and pre-hospital settings.
The Ambu® Oval Resuscitator is a reusable. The range of application for the sizes are: Adult: Adults and children with a body weight of more than approx. 30 kg (66 lbs.) Pediatric: Infants and children with a body weight between approx. 10-30 kg (22-66 lbs).
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510(k) Application – Ambu® Oval Silicone Resuscitator
Summary of the technological characteristics in comparison to the predicate devices
Ambu Oval Resuscitators. Adult is substantially equivalent to:
The operation and technological characteristics of Ambu Oval Resuscitator, Adult is the same as the predicate devices operation and technological characteristics; The only difference is that Ambu Mark IV Resuscitator is a double wall design, while Oval Resuscitator is single wall design.
All devices have the same intended use.
Ambu concludes that the Ambu Oval Resuscitators, Adult is substantially equivalent to the predicate devices.
Ambu Oval Resuscitators, Pediatric is substantially equivalent to:
The operation and technological characteristics of Ambu Oval Resuscitator, Pediatric is the same as the predicate devices operation and technological characteristics; The only difference is that Ambu Mark IV Resuscitator is a double wall design, while Oval Resuscitator is single wall design.
All devices have the same intended use.
Ambu concludes that the Ambu Oval Resuscitators, Pediatric is substantially equivalent to the predicate devices.
Performance Data - Bench
The following data has been submitted in the premarket notification:
- Ambu has provided declaration of conformity to the following recognized . consensus standards ISO 10651-4 and ISO 5356-1
- Test reports for Biocompatibility shows that the devices complies with the . requirements of ISO 10993-1:
- Cytotoxicity (ISO 10993-5) -
- Sensitization (ISO 10993-10) -
- Intracutaneous reactivity test (ISO 10993-10)
- Data to demonstrate Automated Cleaning Validation and Steam Sterilization . Validation According to AAMI TIR 12 and AAMI TIR 30
Bench testing was performed and the results of such bench testing demonstrate that the device is as safe and effective as the currently marketed predicate devices.
Performance Data - Clinical:
No clinical tests are performed
Conclusion:
Based on the indication for use, operation and technological characteristics, and performance testing it has been concluded that the Ambu Oval Resuscitator, Adult and Pediatric have equivalent functionality and intended use as the predicate devices. It is concluded that Ambu Oval Resuscitator, Adult and Pediatric are as safe and effective and performs as well as the legally marketed predicate devices.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ambu A/S C/O Mr. Sanjay Parikh Ambu Incorporated 6740 Baymeadow Drive Glen Burnie, Maryland 21060
JAN 2 8 2011
Re: K102824
Trade/Device Name: Ambu Oval Silicone Resuscitator, Adult and Pediatric Regulation Number: 21 CFR 868.5915 Regulation Name: Manual Emergency Ventilator Regulatory Class: II Product Code: BTM Dated: January 12, 2011 Received: January 13, 2011
Dear Mr. Parikh:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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- Mr. Parikh
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Wh for
Anthony D. Watson. B.S., M.S., M.B.A. 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): Not known
Device Name: Ambu Oval Silicone Resuscitator, Adult and Pediatric
Indications For Use:
The Ambu® Oval Silicone resuscitator is intended for manual pulmonary resuscitation and emergency respiratory support.For use by CPR-trained personnel only, in hospital and pre-hospital settings.
The Ambu Oval Silicone resuscitator is reusable. The range of application for the sizes are:
Adult: Adults and children with a body weight of more than approx. 30 kg (66 lbs.). Paediatric: Infants and children with a body weight between approx. 10-30 kg (22~66 lbs.)
જ્ઞ 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)
h
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices (Division Sign-Off) Division of Anesthesis. Division of Anestion Control, Dental Devices Infection Control, Dental Control, Dental Control, Dental Control, Dental Control, Control, Control, Cont 510 (k) Number: - Led
510(k) Number..
§ 868.5915 Manual emergency ventilator.
(a)
Identification. A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).