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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the MedSource CPR Mask, based on the provided text:

MedSource CPR Mask: Acceptance Criteria and Study Details

The provided document describes a 510(k) premarket notification for the MedSource CPR Mask, which focuses on demonstrating substantial equivalence to predicate devices rather than proving novel clinical efficacy. Therefore, the "acceptance criteria" are related to performance standards and biocompatibility, not clinical outcomes for patients. The "study" refers to the performance testing and biocompatibility assessments conducted.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from the performance expected of similar devices and recognized consensus standards, particularly AS-4259-1995 for respiratory resistance and ISO 10993 for biocompatibility.

Acceptance Criteria Category	Specific Criteria / Standard Reference	MedSource CPR Mask Performance	Predicate Device Performance (Spiracle CPR Mask)
Inspiratory Resistance	AS-4259-1995 methods (Implicit criterion: generally comparable to predicate, ideally lower)	1.94 cm H2O @ 50 lpm flow	2.04 cm H2O @ 50 lpm flow
Expiratory Resistance	AS-4259-1995 methods (Implicit criterion: generally comparable to predicate, ideally lower)	2.04 cm H2O @ 50 lpm flow	2.14 cm H2O @ 50 lpm flow
Cytotoxicity	ISO 10993 Requirement	Passes	Not applicable (raw material testing)
Sensitization	ISO 10993 Requirement	Passes	Not applicable (raw material testing)
Irritation / Intracutaneous Reactivity	ISO 10993 Requirement	Passes	Not applicable (raw material testing)
Pyrogen	ISO 10993 Requirement (Not required, but tested as "beyond requirements")	Passes	Not applicable (raw material testing)
Haemocompatibility	ISO 10993 Requirement (Not required, but tested as "beyond requirements")	Passes	Not applicable (raw material testing)
Systemic Toxicity	ISO 10993 Requirement (Not required, but tested as "beyond requirements")	Passes	Not applicable (raw material testing)

Discussion of Results: The MedSource CPR Mask showed better performance (lower resistance) than the predicate device (Spiracle CPR Mask) for both inspiratory and expiratory resistance. The difference was stated as 5%, deemed to demonstrate "substantially the same performance" given inherent variations in test methods. All required and extra biocompatibility tests were passed.

2. Sample Size and Data Provenance

Test Set Sample Size: For the respiratory resistance testing, the exact number of individual devices or tests performed is not specified, but the results are presented as single values for "MedSource CPR Mask" and "Spiracle CPR Mask," implying a representative sample was tested and reported.
Data Provenance: The testing was presumably conducted by or for MedSource International, LLC as part of their submission to the FDA. The specific country of origin for the data is not stated, but the manufacturer is based in Minnesota, USA. The testing is prospective as it was specifically performed to support the 510(k) submission.

3. Number of Experts and Qualifications for Ground Truth

Not Applicable. This type of device (CPR mask) and submission (510(k) for substantial equivalence) typically relies on objective performance measurements (like resistance) and standardized biocompatibility tests, not subjective expert assessment of images or clinical outcomes that require establishing a "ground truth" through expert consensus.

4. Adjudication Method for the Test Set

Not Applicable. As mentioned above, there was no expert assessment or adjudication process involved in performance or biocompatibility testing. The results are objective measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study is relevant for diagnostic devices where human readers interpret results, often with and without AI assistance, to assess changes in accuracy or efficiency. This type of study is not applicable to a CPR mask, which is a physical medical device for mechanical assistance, not a diagnostic tool requiring interpretation.

6. Standalone (Algorithm Only) Performance Study

Not Applicable. This is not an AI-powered device or algorithm. The performance testing was for the physical device itself.

7. Type of Ground Truth Used

Objective Measurements and Standardized Test Results:
- For respiratory resistance: The "ground truth" is the measured physical property of the device (pressure drop at a given flow rate) as determined by methods outlined in AS-4259-1995.
- For biocompatibility: The "ground truth" is determined by standardized laboratory assays (e.g., cell culture for cytotoxicity, animal models for sensitization/irritation) that assess biological responses to the materials, against passing criteria defined by ISO 10993.

8. Sample Size for the Training Set

Not Applicable. There is no "training set" as this is not an AI/machine learning device. The design, materials, and manufacturing processes are developed through traditional engineering methods, not data-driven machine learning training.

9. How the Ground Truth for the Training Set was Established

Not Applicable. As there is no training set, this question is not relevant.

Summary

{0}------------------------------------------------

ubmitter:

K081516

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) .
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):

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	PatientContact	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 EquivalentComparison Point	Predicate Devices	Result of Comparison
Intended Use	Laerdal® Pocket Mask With andwithout oxygen port K861401Foremount Pocket Size ResuscitatorK042727	Substantially equivalent
Technological Characteristics(Materials of Construction,Dimensions, Performance inexpiratory and inspiratoryresistance)	Spiracle Pocket Size ResuscitatorK042727Laerdal® Pocket Mask K861401	Materials of construction-same or similarPerformance-minorvariationsDimensions-minor variations
Instructions for Use	Spiracle Pocket Size ResuscitatorK042727Laerdal® 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 doperformance testing
IS 4259-1995	Ancillary Devices for Expired Air Resuscitation.	Used as a guide but did not doperformance testing
ISO10993-1edition-1997-12-15	(2nd Biological Evaluation Of Medical Devices—Part1: 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:

1. The results in the above table demonstrate that the MedSource CPR Mask performance exceeds the performance of the predicate device.
1. 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

BiocompatibilityTest	ISO 10993 Requirement	Testing results
Cytotoxicity	Required	Passes
Sensitization	Required	Passes
IrritationorIntracutaneousreactivity	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:

1. The raw materials have been tested beyond the requirements of ISO 10993 for skin contact.
1. The time of contact and percentage of body exposure is very low.
1. 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 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

Page 1 of 1

Regulation Number and Section

§ 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).