(231 days)
Infant Manual Resuscitator: The 1st Response Infant Manual Resuscitator is a pulmonary-assist device intended to provide respiratory support to infant patients suffering from respiratory distress. It is intended for use on patients with a body mass of < 10 kg (22 lbs).
Pediatric Manual Resuscitator: The 1* Response Pediatric Manual Resuscitator is a pulmonary-assist device intended to provide respiratory support to pediatric patients suffering from respiratory distress. It is intended for use on patients with a body mass of > 10 kg (22 lbs) and <25 kg (55 lbs).
The 1st Response infant and pediatric manual resuscitators are disposable, single use emergency manual ventilators. Each device consists of a plastic compressible ventilator bag fitted with control valves at each of the two ends.
The inlet valve, opposite the patient end, allows entry of fresh gas into the compressible ventilator bag. The valve blocks escape of fresh gas from the ventilator bag during its compression. Attached to this valve are one of two types of reservoirs; bag reservoir or tube reservoir. These reservoirs serve to collect an overflow of oxygen when a supplemental oxygen supply is used.
The patient end of the ventilator bag is fitted with a second valve assembly. This valve consists of a 15mm ID x 22 mm OD patient connector, exhalation port, manometer port, and a pressure limiting valve (PLV).
The device is provided with or without a face mask. Special configurations are available which include a disposable manometer, PEEP valve with adapter, or exhalation filter.
The provided document describes a 510(k) premarket notification for the SIMS Portex Inc. 1st Response Infant and Pediatric Manual Resuscitator. This is a submission for a medical device that demonstrates substantial equivalence to existing predicate devices, rather than a study proving the device meets acceptance criteria through clinical trials or performance metrics that would typically be described with the requested information.
Therefore, the specific information requested about acceptance criteria, detailed study design, sample sizes, expert involvement, and ground truth establishment (which are common for AI/software-based medical devices or novel medical devices requiring extensive performance studies) is not applicable in the context of this 510(k) submission for a manual resuscitator.
Here's how the available information relates to your request:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
Not Applicable. The document does not present specific quantitative acceptance criteria or reported device performance in a table format as would be typical for a clinical or performance study of a novel device. Instead, the "acceptance" in this context is based on demonstrating substantial equivalence to predicate devices, meaning it meets the same standards and performs similarly to devices already on the market.
The document states:
- "Performance and specifications of the modified device are consistent with all requirements for this device type specified by ISO 8382:1988 (E) Resuscitators intended for use with humans and ISO 5356-1: 1987 - Anaesthetic and respiratory equipment -Conical connectors - Part 1: Cones and sockets." (Page 2)
This indicates that the device meets existing international standards for medical resuscitators, which serve as the implicit "acceptance criteria" for its design and manufacturing.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not Applicable. This submission is for a physical medical device (manual resuscitator) and relies on "non-clinical data" (Page 2), primarily engineering and design specifications, and comparison to predicate devices, rather than a "test set" of patient data as might be used for an AI algorithm or a diagnostic device. There is no mention of a test set, data provenance, or patient data collection.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable. There was no "test set" in the context of patient data where ground truth would be established by experts. The determination of substantial equivalence is made by regulatory bodies (FDA) based on the submitted technical documentation and comparison to predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable. As no test set of patient data was used, no adjudication method for ground truth establishment was necessary or performed.
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
Not Applicable. This is a manual resuscitator, not an AI or diagnostic imaging device. Therefore, no MRMC study or AI assistance is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is a physical medical device; there is no algorithm involved.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not Applicable. For this type of device submission, the "ground truth" or basis for approval is adherence to established industry standards (ISO 8382:1988 (E) and ISO 5356-1: 1987) and demonstrated substantial equivalence in technical characteristics, indications for use, and safety/effectiveness to previously cleared predicate devices.
8. The sample size for the training set
Not Applicable. There is no "training set" as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
Not Applicable. There is no "training set" or associated ground truth.
Summary of the Study/Justification Presented in the Document:
The "study" in this context is a non-clinical comparative analysis demonstrating an equivalence to legally marketed predicate devices.
- Objective: To demonstrate that the 1st Response Infant and Pediatric Manual Resuscitator is substantially equivalent to existing predicate devices in terms of safety and effectiveness.
- Methodology: Comparison of technical characteristics, indications for use, and performance against established international standards (ISO 8382:1988 (E) and ISO 5356-1: 1987).
- Predicate Devices:
- Hudson Respiratory Care Inc., Neonate Manual Resuscitator, Cat. No. 5360 and Pediatric Manual Resuscitator, Cat. No. 5365.
- SIMS Portex Inc., 1st Response Infant Manual Resuscitator, Cat. No. 008027MP and 1st Response Pediatric Manual Resuscitator Cat. No. 008120.
- Conclusion: "The comparison to the predicate devices demonstrate that the proposed devices are safe and effective and are substantially equivalent to the predicate devices." (Page 2)
This type of submission focuses on regulatory compliance and equivalence rather than detailed clinical trial data with specific acceptance criteria and performance metrics for a novel technology.
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JAN 18 2000
SIMS Portex Inc.
10 Bowman Drive PO Box 0724 Keene NH 03431 USA Telephone: 603-352-3812 Fax: 603-352-3703
H: 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
510(K) SUMMARY:
COMPANY INFORMATION:
SIMS Portex Inc 10 Bowman Drive Keene, NH 03431 (603) 352-3812 Contact: Timothy J. Talcott Manager, Regulatory Affairs
PREPARATION DATE OF SUMMARY:
May 28, 1999
TRADE NAME:
1st Response Infant Manual Resuscitator 1st Response Pediatric Manual Resuscitator
COMMON NAME:
Manual Resuscitator
PRODUCT CLASS/CLASSIFICATION:
Class II, 73 BTM, 21 CFR 868.5915
PREDICATE DEVICE(S):
Hudson Respiratory Care Inc., Temecula California, Neonate Manual Resuscitator, Cat. No. 5360 and Pediatric Manual Resuscitator, Cat. No. 5365.
SIMS Portex Inc., Ft. Myers Florida, 1st Response Infant Manual Resuscitator, Cat. No. 008027MP and 1st Response Pediatric Manual Resuscitator Cat. No. 008120
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DESCRIPTION:
The 1st Response infant and pediatric manual resuscitators are disposable, single use emergency manual ventilators. Each device consists of a plastic compressible ventilator bag fitted with control valves at each of the two ends.
The inlet valve, opposite the patient end, allows entry of fresh gas into the compressible ventilator bag. The valve blocks escape of fresh gas from the ventilator bag during its compression. Attached to this valve are one of two types of reservoirs; bag reservoir or tube reservoir. These reservoirs serve to collect an overflow of oxygen when a supplemental oxygen supply is used.
The patient end of the ventilator bag is fitted with a second valve assembly. This valve consists of a 15mm ID x 22 mm OD patient connector, exhalation port, manometer port, and a pressure limiting valve (PLV).
The device is provided with or without a face mask. Special configurations are available which include a disposable manometer, PEEP valve with adapter, or exhalation filter.
INDICATIONS FOR USE:
Infant Manual Resuscitator
The 18 Response Infant Manual Resuscitator is a pulmonary-assist device intended to provide respiratory support to infant patients suffering from respiratory distress. It is intended for use on patients with a body mass of < 10 kg (22 lbs).
Pediatric Manual Resuscitator
The 1* Response Pediatric Manual Resuscitator is a pulmonary-assist device intended to provide respiratory support to pediatric patients suffering from respiratory distress. It is intended for use on patients with a body mass of > 10 kg (22 lbs) and <25 kg (55 lbs).
TECHNICAL CHARACTERISTICS:
The device has the same technical characteristics as the predicate device marketed by Hudson Respiratory Care Inc. and our manual resuscitators.
NON-CLINICAL DATA:
Performance and specifications of the modified device are consistent with all requirements for this device type specified by ISO 8382:1988 (E) Resuscitators intended for use with humans and ISO 5356-1: 1987 - Anaesthetic and respiratory equipment -Conical connectors - Part 1: Cones and sockets.
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CONCLUSION:
The comparison to the predicate devices demonstrate that the proposed devices are safe and effective and are substantially equivalent to the predicate devices.
Very truly yours,
SIMS PORTEX INC.
Timothy J. Talbot
Timothy J. Takott Manager, Regulatory Affairs
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 18 2000
Mr. Timothy J. Talcott SIMS Portex Inc. 10 Bowman Drive P.O. Box 0724 Keene, NH 03431
Re : K991861 186 Response Infant and Pediatric Manual Resuscitator Regulatory Class: II (two) Product Code: 73 BTM Dated: October 28, 1999 Received: October 29, 1999
Dear Mr. Talcott:
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 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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.
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Page 2 - Mr. Timothy J. Talcott
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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at Also, please note the regulation entitled, (301) 594-4639. "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/dsma/dsmamain.html".
Sincerely yours,
Jeans A Westerlun for,
Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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B: INTENDED USE OF DEVICE
PROPOSED INDICATIONS FOR USE:
Page 1 of 1
510(k) Number (if known): Unknown
Device Name: 1* Response Infant and Pediatric Manual Resuscitator
Indications For Use:
Infant Manual Resuscitator
The 1st Response Infant Manual Resuscitator is a pulmonary-assist device intended to provide respiratory support to infant patients suffering from respiratory distress. It is intended for use on patients with a body mass of < 10 kg (22 lbs).
Pediatric Manual Resuscitator
The 1* Response Pediatric Manual Resuscitator is a pulmonary-assist device intended to provide respiratory support to pediatric patients suffering from respiratory distress. It is intended for use on patients with a body mass of > 10 kg (22 lbs) and <25 kg (55 lbs).
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (QDE)
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
Neurological Devices
| Prescription Use | ✓ |
|---|---|
| OR Over-The-Counter Use | |
| 510(k) Number | K991861 |
§ 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).