(88 days)
Not Found
No
The device description and performance studies focus on mechanical properties and do not mention any computational or data-driven features indicative of AI/ML.
Yes
The device is designed to provide immediate life support by assisting in mouth-to-mask ventilation, which is a therapeutic intervention aimed at supporting respiration for individuals requiring oxygen or CPR.
No
The device is a CPR mask, which is used to assist in providing immediate life support (ventilation) during emergencies, not to diagnose a medical condition.
No
The device description clearly outlines physical components (mask, tube, valve, head strap) and performance studies focus on physical characteristics like resistance, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- MedSource CPR Mask Function: The MedSource CPR Mask is a device used to directly assist in providing ventilation and oxygen to a person during a medical emergency. It is used on the body, not to test samples taken from the body.
- Intended Use: The intended use clearly states it's for "providing immediate life support (mouth to mask ventilation)" and "requiring oxygen support (inhalation) or cardiopulmonary resuscitation (CPR) rescue techniques." This is a direct intervention, not a diagnostic test.
- Device Description: The description details a mask, valve, and strap – components for delivering air and oxygen, not for analyzing biological samples.
- Performance Studies: The performance studies focus on physical characteristics like inspiratory and expiratory resistance, which are relevant to the function of a ventilation device, not a diagnostic test.
The MedSource CPR Mask is a medical device, but it falls under a different category than In Vitro Diagnostics. It's a device used for direct patient care and intervention.
N/A
Intended Use / Indications for Use
The MedSource CPR Mask is designed to assist in providing immediate life support (mouth to mask ventilation) to health emergency victims requiring oxygen support (inhalation) or cardiopulmonary resuscitation (CPR) rescue techniques. The MedSource CPR Mask is designed to assist in providing immediate life support (mouth to mask ventilation) to health emergency victims requiring cardiopylmonary resuscitation (CPR) resue techniques. The MedSource CPR Mask is designed to assist in providing immediate life support (mouth to mask ventilation) to health emergency victims requiring oxygen support (inhalation) or cardiopulmonary resuscitation (CPR) rescue techniques. The CPR Mask with Oxygen Port is for prescription use.
Product codes (comma separated list FDA assigned to the subject device)
CBP
Device Description
A one piece, single use, full-size, light-weight PVC mask system which includes: A Universal breathing tube. A One-way filtered valve. A Head strap. With Oxygen Port or Without Oxygen Port. Packaged for easy portability and quick access.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Mouth, Skin/Hair
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Expiratory And Inspiratory Resistance Performance testing was done using the test methods described in AS-4259-1995, Ancillary Devices for Expired Air Resuscitation. Some minor modifications were made to the e methods. Results showed MedSource CPR Mask: Inspiratory Resistance 1.94 cm H2O @ 50 lpm flow, Expiratory Resistance 2.04 cm H2O @ 50 lpm flow. Spiracle CPR Mask: Inspiratory Resistance 2.04 cm H2O @ 50 lpm flow, Expiratory Resistance 2.14 cm H2O @ 50 lpm flow. The MedSource CPR Mask performance exceeds the performance of the predicate device. For both inspiratory and expiratory resistance, the difference between the MedSource CPR mask and the Spiracle foldable mask is 5%. This demonstrates that the MedSource CPR Mask performance and the Spiracle foldable mask perform substantially the same test conditions assuming there are inherent variations in the test methods. Accuracy and repeatability are not discussed in the AS 4259-1995 standard.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
Not Found
§ 868.5870 Nonrebreathing valve.
(a)
Identification. A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.(b)
Classification. Class II (performance standards).
0
ubmitter:
MedSource International, LLC 5346 Shoreline Drive Mound, Minnesota 55364 952-472-0131
Contact/Consultant:
AUG 2 6 2008
Howard Cooper, Quality Consultant EQACT, INC. 317-826-4398 (O) 317-826-4398(F) 317-523-2314 (C) htc@eqact.com
General Information
.
- Common or Usual Name: Emergency CPR Mask .
- Proprietary Name: MedSource CPR Mask With Oxygen Port (Prescription Use)
- MedSource CPR Mask Without Oxygen Port (Over-the-Counter Use) .
- Proprietary Name: MedSource CPR Mask With Oxygen Port (Prescription Use)
- Product Code:CBP .
- . Panel: Anesthesiology
- Classification: . Class II
- Regulatory Reference: 21 CFR §868.5870 .
- Single Use: Yes .
- Sterile: No .
- Packaging Materials: PE & PET Polymer film and medical package paper using heat as . the sealing method
Indications for Use (with Oxygen Port):
The MedSource CPR Mask is designed to assist in providing immediate life support (mouth to mask ventilation) to health emergency victims requiring oxygen support (inhalation) or cardiopulmonary resuscitation (CPR) rescue techniques.
Indications for Use (without Oxygen Port):
The MedSource CPR Mask is designed to assist in providing immediate life support (mouth to mask ventilation) to health emergency victims requiring cardiopylmonary resuscitation (CPR) resue techniques.
1
Tevice Characteristics:
The MedSource CPR Mask has the following characteristics:
A one piece, single use, full-size, light-weight PVC mask system which includes:
- A Universal breathing tube. .
- A One-way filtered valve. .
- A Head strap. .
- With Oxygen Port or Without Oxygen Port. .
- Packaged for easy portability and quick access. .
Patient Contact
| Device Component | Material of Construction | Patient
Contact | Contact Time |
|-------------------|--------------------------|--------------------|--------------|
| CPR one-way valve | PVC/Silicon valve | Mouth | 3-60 minutes |
| Face Mask | PVC | Skin | 3-60 minutes |
| Strap | Non-Woven | Skin/Hair | 3-60 minutes |
| Suggestively Equivalent
| Comparison Point | Predicate Devices | Result of Comparison |
|---|---|---|
| Intended Use | Laerdal® Pocket Mask With and | |
| without oxygen port K861401 | ||
| Foremount Pocket Size Resuscitator | ||
| K042727 | Substantially equivalent | |
| Technological Characteristics | ||
| (Materials of Construction, | ||
| Dimensions, Performance in | ||
| expiratory and inspiratory | ||
| resistance) | Spiracle Pocket Size Resuscitator | |
| K042727 | ||
| Laerdal® Pocket Mask K861401 | Materials of construction- | |
| same or similar | ||
| Performance-minor | ||
| variations | ||
| Dimensions-minor variations | ||
| Instructions for Use | Spiracle Pocket Size Resuscitator | |
| K042727 | ||
| Laerdal® Pocket Mask K861401 | Very similar |
Recognized Consensus Standards:
| Standard | Title | Status of Compliance |
|---|---|---|
| ISO 5356-1:2004 | Anaesthetic and Respiratory Equipment - | |
| Conical Connectors: Part 1: Cones and Sockets. | Used as a guide but did not do | |
| performance testing | ||
| IS 4259-1995 | Ancillary Devices for Expired Air Resuscitation. | Used as a guide but did not do |
| performance testing | ||
| ISO10993-1 | ||
| edition-1997-12-15 | (2nd Biological Evaluation Of Medical Devices—Part | |
| 1: Evaluation and Testing | Compliant to applicable sections |
2
510(K) Summary for the MedSource CPR Mask
Performance Testing
Expiratory And Inspiratory Resistance Performance testing was done using the test methods described in AS-4259-1995, Ancillary Devices for Expired Air Resuscitation. Some minor modifications were made to the e methods
| Device Tested | Inspiratory Resistance | Expiratory Resistance |
|---|---|---|
| MedSource CPR Mask | 1.94 cm H2O @ 50 lpm flow | 2.04 cm H2O @ 50 lpm flow |
| Spiracle CPR Mask | 2.04 cm H2O @ 50 lpm flow | 2.14 cm H2O @ 50 lpm flow |
Discussion of Results:
-
- The results in the above table demonstrate that the MedSource CPR Mask performance exceeds the performance of the predicate device.
-
- For both inspiratory and expiratory resistance, the difference between the MedSource CPR mask and the Spiracle foldable mask is 5%. This demonstrates that the MedSource CPR Mask performance and the Spiracle foldable mask perform substantially the same test conditions assuming there are inherent variations in the test methods... Accuracy and repeatability are not discussed in the AS 4259-1995 standard.
iocompatibility
Raw Material Biocompatibility Testing
| Biocompatibility
| Test | ISO 10993 Requirement | Testing results |
|---|---|---|
| Cytotoxicity | Required | Passes |
| Sensitization | Required | Passes |
| Irritation | ||
| or | ||
| Intracutaneous | ||
| reactivity | Required | Passes |
| Pyrogen | Not required | Passes |
| Haemocompatibility | Not required | Passes |
| Systemic Toxicity | Not required | Passes |
Conclusion:
The potential for causing irritation is very remote for the following reasons:
-
- The raw materials have been tested beyond the requirements of ISO 10993 for skin contact.
-
- The time of contact and percentage of body exposure is very low.
-
- The injection molding process is not significantly alter the raw material characteristics
3
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MedSource International, LLC C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW Buffalo, Minnesota 55313
AUG 2 6 2008
Re: K081516
Trade/Device Name: MedSource CPR Mask with Oxygen Port / Model PM103 MedSource CPR Mask / Model PM104 Regulation Number: 21 CFR 868.5870 Regulation Name: Nonrebreathing Valve Regulatory Class: II Product Code: CBP Dated: August 20, 2008 Received: August 21, 2008
Dear Mr. Job:
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.
4
Page 2 - Mr. Job
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 (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. 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
Ove
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
Enclosures
5
Indications for Use
510(k) Number (if known):
Device Name: MedSource CPR Mask with Oxygen Port / Model PM103
Indications for Use:
The MedSource CPR Mask is designed to assist in providing immediate life support (mouth to mask ventilation) to health emergency victims requiring oxygen support (inhalation) or cardiopulmonary resuscitation (CPR) rescue techniques.
The CPR Mask with Oxygen Port is for prescription use.
Prescription Use X (Part 21 CFR 801 Subpart D) 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)
Vhls
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K081516
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