(285 days)
The intended use for this device is to provide emergency respiratory support for Adult, Child and Infant.
The device is a disposable, single patient use manual resuscitator that includes a compression bag, intake and patient valve, and a closed vinyl oxygen reservoir bag, (options: open corrugated tubing or open expandable tubing in lieu of closed vinyl oxygen reservoir bag), and an optional peep valve and/or face mask.
Here's an analysis of the provided text regarding the acceptance criteria and study for the BriGam Manual Resuscitator (K963848):
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes tests performed on components of the manual resuscitator, rather than overall device performance metrics like efficacy in ventilation. The tests are focused on biocompatibility and physicochemical characteristics of materials in indirect contact with the patient.
| Item | Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Rubber Compression Bag (A) | 1. Cytotoxicity | Minimal or no cytotoxicity | "slight" cytotoxic |
| Rubber Compression Bag (A) | 2. Physiochemical (Elastomeric Closures) | Appropriate physicochemical extraction characteristics (implied for safety/material integrity) | Performed, but specific results not quantified beyond "pertinent" characteristics |
| Rubber Compression Bag (A) | 3. ASTM Protein Analysis | Protein levels below a safe threshold | < 50 ug of protein per gram of material |
| Vinyl Reservoir Bag (B) | 1. Cytotoxicity | Minimal or no cytotoxicity | "none" cytotoxic |
| Vinyl Reservoir Bag (B) | 2. Physiochemical (Elastomeric Closures) | Appropriate physicochemical extraction characteristics (implied for safety/material integrity) | Performed, but specific results not quantified beyond "pertinent" characteristics |
| Silicone Rubber Lip Valve (C) | 1. Cytotoxicity | Minimal or no cytotoxicity | "none" cytotoxic |
| Silicone Rubber Lip Valve (C) | 2. Physiochemical (Elastomeric Closures) | Appropriate physicochemical extraction characteristics (implied for safety/material integrity) | Performed, but specific results not quantified beyond "pertinent" characteristics |
| Silicone Rubber Lip Valve (C) | 3. ASTM Protein Analysis | Protein levels below a safe threshold | < 50 ug of protein per gram of material |
Note: The acceptance criteria for "slight" cytotoxicity would need further context from the testing standard or internal protocols. It suggests that while some cytotoxicity was observed, it was deemed acceptable within a defined safety margin for the intended use and indirect contact. The "pertinent physiochemical extraction characteristics" are not detailed, but likely refer to the absence of excessive leaching of harmful substances.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for the individual tests (Cytotoxicity, Physiochemical, ASTM Protein Analysis) of the components.
- Data Provenance: The tests appear to be conducted by or on behalf of the manufacturer, BriGam Medical Co. The country of origin for the data is not explicitly stated, but given the company's address in Newland, NC, USA, and the FDA submission, it can be inferred that the testing was likely performed in the USA. The data is prospective in the sense that these tests were performed specifically for the 510(k) submission to demonstrate substantial equivalence, rather than being collected retrospectively from existing records.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to the tests described. The tests performed are laboratory-based material characterization tests (biocompatibility and physicochemical properties), not clinical studies requiring expert interpretation of diagnostic images or patient outcomes. The "ground truth" for these tests would be established by the results of standardized laboratory protocols and measurements, interpreted by laboratory technicians or scientists.
4. Adjudication Method for the Test Set
This information is not applicable for the reasons stated above. Adjudication methods (like 2+1, 3+1) are used in clinical studies, particularly for interpreting ambiguous findings, typically by multiple experts.
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, an MRMC comparative effectiveness study was not done. The device is a manual resuscitator, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This device is a physical medical device, not a software algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the tests performed is based on laboratory standards and measurements.
- For Cytotoxicity: This would typically involve visual assessment of cell morphology and viability relative to controls, following established standards (e.g., ISO 10993-5). The "scoring (reactivity)" as "slight" or "none" is a direct outcome of this assessment.
- For Physiochemical: This involves analytical chemistry techniques to identify and quantify extractables from the materials, with "ground truth" being the measured chemical profiles compared against known harmful substances or acceptable limits.
- For ASTM Protein Analysis: This involves a quantitative biochemical assay to measure protein concentration, with the "ground truth" being the measured protein level in micrograms per gram of material, compared against a specified threshold.
8. The Sample Size for the Training Set
There is no training set as this is a physical medical device, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the reasons stated above.
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Image /page/0/Picture/0 description: The image contains a sequence of alphanumeric characters, specifically 'KC963848'. The characters are handwritten in a clear, legible style. The sequence appears to be a code or identifier, possibly a serial number or reference number.
Image /page/0/Picture/1 description: The image shows the word "BriGam" in a bold, sans-serif font. The letters are black against a white background. The word appears to be a logo or brand name.
1
Post Office Box 1009
Morganton, N.C. 28680-1009
TEL. 704-437-0236 FAX. 704-437-7695
510(K) Summary for K963848
Submitter's Name: Address:
Phone #: FAX: Contact Person: Date Summary Prepared:
Proprietary Name: Common Name: Classification Name: Bill Brooks 65 Hanes Road Newland, NC 28657 (704) 733-8121 (704) 733-8741 Bill Brooks 12/17/96
JUL - 7 1997
Manual Resuscitator Manual Emergency Ventilator Manual Emergency Ventilator (per CFR section 868.5915)
Marketed Device to Whom we are claiming equivalence:
Our device is substantially equivalent to the currently marketed device by Mercury @
CPR Bag) Medical and Ambu Spur Resuscitator) Inc.
Description of the Device:
The device is a disposable, single patient use manual resuscitator that includes a compression bag, intake and patient valve, and a closed vinyl oxygen reservoir bag, (options: open corrugated tubing or open expandable tubing in lieu of closed vinyl oxygen reservoir bag), and an optional peep valve and/or face mask.
Intended Use: The intended use for this device is to provide emergency respiratory support for Adult, Child and Infant.
Technological Characteristics of our device compared to the predicate device:
The technological characteristics of Owens-BriGam Manual Resuscitator are substantial equivalent to Mercury Medical and Ambu Inc. Medical Resuscitator. BriGam's Manual Resuscitator is of generally the same form and intended to be used in the same manner as the substantially equivalent products as outlined in Exhibit E.
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BriGam
Post Office Box 1009
Morganton, N.C. 28680-1009
TEL. 704-437-0236 FAX. 704-437-7695
Test Summary:
The resuscitator does not come in direct contact with the patient, although the following tests were performed on the vinyl compression bag, rubber reservoir bag and the silicone rubber lip valve.
| Item | Test | |
|---|---|---|
| A. | Rubber Compression Bag | 1. Cytotoxicity2. Physiochemical (Elastomeric Closures)3. ASTM Protein Analysis |
| B. | Vinyl Reservoir Bag | 1. Cytotoxicity2. Physiochemical (Elastomeric Closures) |
| C. | Silicone Rubber Lip Valve | 1. Cytotoxicity2. Physiochemical (Elastomeric Closures)3. ASTM Protein Analysis |
The scoring (reactivity) for cytotoxicity of item A was noted as "slight" cyrotoxic and items B and C noted as "none" cytotoxic. In addition physiochemical tests were performed for items A B, and C to determine pertinent physiochemical extraction characteristics.
ASTM Protein analysis was performed on items A and C and the results were <50 ug of protein per gram of material.
BriGam Medical Co. believes that this information and referred exhibits and attachments to be sufficient for the FDA to find our proposed device substantially equivalent to other products currently in distribution.
Bill Bradley
Bill Brooks Regulatory Affairs/Quality Assurance Director Official Correspondent BriGam Medical Co.
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Image /page/2/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a simple, sans-serif font and is horizontally aligned. The text is likely part of a document or sign, indicating an affiliation with a public health organization.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Image /page/2/Picture/10 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized caduceus symbol. The caduceus is depicted with a staff entwined by a serpent, representing medicine and healing. The seal is in black and white.
JUL - 7 1997
Mr. Bill Brooks Owens-BriGam Medical Company Post Office Box 1009 Morganton, North Carolina 28680-1009
Re: K963848 Manual Resuscitator Requlatory Class: II (two) Product Code: 73 BTM Dated: May 12, 1997 Received: May 15, 1997
Dear Mr. Brooks:
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 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, labelinq, 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 requlatory 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. Bill Brooks
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 (301) 594-4639. Also, please note the regulation entitled, "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/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page / of /
K963848 510(k) Number (if known):_
Device Name: Tou 11 0.
Indications For Use:
organu
The intended use for this device is to provide
support for Adult,
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jo H. Westerhaus
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number _
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use __
(Optional Format 1-2-96)
§ 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).