(83 days)
Not Found
No
The device description and intended use clearly describe a manual, spring-actuated resuscitator and PEEP valve. There is no mention of any computational or algorithmic components, let alone AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is a manual resuscitator and a positive end expiratory pressure (PEEP) valve, both of which are used to temporarily ventilate patients and elevate lung pressure, providing therapy for ventilatory insufficiency or failure.
No
The device is a manual resuscitator and a PEEP valve, used to temporarily ventilate patients or elevate lung pressure. Its function is interventional (providing ventilation/pressure), not diagnostic (identifying or characterizing a disease or condition). While the PEEP valve is described as used "to evaluate end lung pressure," its primary role is to provide and maintain that pressure, not to diagnose a condition based on a measurement it takes or processes.
No
The device description clearly states that the devices are "disposable, medical devices" and describes physical components like a "duck-bill valve," "non-rebreathing valve assembly," "ventilation bag," "oxygen enrichment (reservoir) system," and "spring actuated valve." These are all hardware components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "temporarily ventilate a patient" and "elevate lung pressure above atmospheric pressure at the end of exhalation." This is a direct therapeutic intervention on the patient's respiratory system.
- Device Description: The device description details a "Manual Resuscitation Bag" and "Disposable PEEP Valves" which are mechanical devices used to assist breathing.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. The device acts directly on the patient's body.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside or directly on the body) to provide respiratory support.
N/A
Intended Use / Indications for Use
Single patient use manual resuscitator for use hospital, transport, emergency, and post hospital care to temporary ventilate a patient for the given body mass ranges of: Infant: 23 Kg
Single patient use manual resuscitator for use hospital, transport, emergency, and post hospital care to temporary ventilate a patient for the given body mass ranges of: Infant: 23 Kg This manual resuscitator is supplied with a single patient use positive end expiratory pressure (PEEP) valve for use hospital, transport, emergency, and post hospital care to evaluate end lung pressure above atmospheric at the end of exhalation in constant and intermittent gas flow conditions.
Single patient use device for use hospital, transport, emergency, and post hospital care for the elevation of lung pressure above atmospheric pressure at the end of exhalation.
Product codes (comma separated list FDA assigned to the subject device)
BTM, BYE
Device Description
DISPO-BAG Manual Resuscitation Bags with and without Disposable PEEP Valve: GaleMed DISPO-BAG Manual Resuscitation Bags are disposable, medical devices which temporarily augment ventilation in patients during ventilatory insufficiency or ventilatory failure.
GaleMed DISPO-BAG Manual Resuscitation Bags use a duck-bill valve in the non-rebreathing valve assembly, attaches the non-rebreathing valve directly onto the ventilation bag and includes an oxygen enrichment (reservoir) system.
GaleMed DISPO-BAG Manual Resuscitation Bags incorporate a number of features, which are designed to allow flexibility in product configuration:
- Adult, child and infant models with and without face mask
- Adult, child and infant models with open and closed oxygen reservoir systems
- Adult, child and infant models with and without a Positive End Expiratory Pressure (P.E.E.P.) device on the expiratory port
Disposable PEEP Valve: GaleMed Disposable PEEP Valves are disposable medical devices which elevate the pressure in a patient's lungs above atmospheric pressure at the end of exhalation. The GaleMed Disposable PEEP Valve is a, spring actuated valve, which when placed into a circuit provides positive end expiratory pressure for the patient. The valve is provided in two pressure ranges (5-20 cmH2O and 2.5 - 10 cm H2O) and several connector sizes which comply to ISO 5356- I "Anesthetic and respiratory equipment -Conical connectors - Part 1: Cones and sockets". Likewise the GaleMed single patient use fixed value PEEP valve is a, spring actuated valve, which when placed into a circuit provides positive end expiratory pressure for the patient. The valve is provided in two pressure settings of 2.4, 5.0, 7.5 and 10.0 cmHzO) also offered in several connector sizes which comply to ISO 5356- I "Anesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets".
GaleMed Disposable PEEP Valve configurations include: - 2.5 - 10.0 cm H2O Adjustable Valve
- 5.0 20.0 cm H2O Adjustable Valve.
- Fixed Valves at 2.5, 5.0, 7.5 and 10 cm H2O.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lungs
Indicated Patient Age Range
Infant (neonate) to adult
Intended User / Care Setting
Hospital, transport, emergency, and post hospital care environments.
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)
Bench testing confirmed the accuracy of the devices.
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
§ 868.5915 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).
0
KOS2019
Image /page/0/Picture/1 description: The image contains a logo with the word "galer" in bold, sans-serif font. The word is positioned on top of a dark, irregular shape that resembles a splattered paint. Below the word "galer", there is a tagline that reads "living for life" in a smaller, more delicate font.
510(k) Summary
OCT 1 5 2008
| Owner: | GaleMed Corporation
97, Li-gong 2nd Road, Wu-jia
I-Lan, Taiwan 268
Tel: + 866 3 990 8618
Fax: + 866 3 990 8245 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Owner/Operator Number: | 8043316 |
| Official Contact: | Thomas Loescher
Tel: (760) 930-4025
Fax: (760) 930-0040 |
| Trade Names: | Resuscitators:
- DISPO-BAG Manual Resuscitation
- Bag DISPO-BAG Manual Resuscitation Bag with Disposable PEEP Valve
P.E.E.P. Valve: Disposable PEEP Valve |
| Common/Usual Name: | Resuscitators:
- Manual Resuscitation
- Manual Resuscitation Bag with PEEP Valve
P.E.E.P. Valve: PEEP Valve |
| Classification Name: | Dispo - Bag Manual Resuscitator:
Device Name: Ventilator, Emergency, Manual (Resuscitator)
Product Code: BTM
Regulation: 868.5915
Device Class: 2
Disposable PEEP Valve:
Device Name: Attachment, Breathing, Positive End Expiratory Pressure
Product Code: BYE
Regulation: 868.5965
Device Class: 2 |
| Device: | Dispo-Bag Manual Resuscitator
Dispo-Bag Manual Resuscitator with Disposable PEEP Valve
Disposable PEEP Valve |
Predicate Devices:
Ventilator, Emergency, Manual (Resuscitator):
| K944301: | Hudson RCI, Temecula, CA (Teleflex Medical, Research Triangle Park, NC);
LIFESAVER® Single patient use Manual Resuscitators; Cat. Nos. 5360, 5361, 5362, 5364, 5365, 5366, 5367, 5369, 5370, 5371, 5372, 5373, 5377, 5380, 5387, and 5389. |
| ---------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
Attachment, Breathing, Positive End Expiratory:
| K902062: | Hudson RCI, Temecula, CA (Teleflex Medical, Research Triangle Park, NC);
LIFESAVER® PEEP Valve; Cat. Nos. 5383 and 5385. |
| ---------- | ----------------------------------------------------------------------------------------------------------------------------- |
|---|
Device Description:
DISPO-BAG Manual Resuscitation Bags with and without Disposable PEEP Valve:
GaleMed DISPO-BAG Manual Resuscitation Bags are disposable, medical devices which temporarily augment ventilation in patients during ventilatory insufficiency or ventilatory failure.
87 Li-gong 200 Road, Wu-jia, I-Lan 268
율. +866-(0)3-990-8618 Fax: +866-(0)3-990-8245
:
Page 1 of 3
1
Image /page/1/Picture/0 description: The image shows a sequence of characters that appear to be handwritten. The characters are 'KOS2C9a', and they are written in a cursive style. The characters are all connected, and they are written in a single line. The image is a close-up of the characters, and the background is white.
Image /page/1/Picture/1 description: The image shows a logo with the word "galer" in a bold, sans-serif font. Below the word "galer" are two lines of smaller text. The first line is a series of dots, and the second line appears to say "caring for life". The logo also includes a dark, abstract shape to the left of the word "galer".
GaleMed DISPO-BAG Manual Resuscitation Bags use a duck-bill valve in the non-rebreathing valve assembly, attaches the non-rebreathing valve directly onto the ventilation bag and includes an oxygen enrichment (reservoir) system.
GaleMed DISPO-BAG Manual Resuscitation Bags may be used in the hospital, in physician office, outpatient care facilities, extended care facility, home, emergency medical services and patient transport.
GaleMed DISPO-BAG Manual Resuscitation Bags incorporate a number of features, which are designed to allow flexibility in product configuration:
- Adult, child and infant models with and without face mask �
- Adult, child and infant models with open and closed oxygen reservoir systems .
- Adult, child and infant models with and without a Positive End Expiratory Pressure . (P.E.E.P.) device on the expiratory port
Disposable PEEP Valve:
GaleMed Disposable PEEP Valves are disposable medical devices which elevate the pressure in a patient's lungs above atmospheric pressure at the end of exhalation. The GaleMed Disposable PEEP Valve is a, spring actuated valve, which when placed into a circuit provides positive end expiratory pressure for the patient. The valve is provided in two pressure ranges (5-20 cmH2O and 2.5 - 10 cm H2O) and several connector sizes which comply to ISO 5356- I "Anesthetic and respiratory equipment -Conical connectors - Part 1: Cones and sockets". Likewise the GaleMed single patient use fixed value PEEP valve is a, spring actuated valve, which when placed into a circuit provides positive end expiratory pressure for the patient. The valve is provided in two pressure settings of 2.4, 5.0, 7.5 and 10.0 cmHzO) also offered in several connector sizes which comply to ISO 5356- I "Anesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets".
GaleMed Disposable PEEP Valves may be used in the hospital, extended care facility, emergency medical services and patient transport. They may be used in a constant or intermittent flow system such as resuscitation bags or continuous gas flow systems.
GaleMed Disposable PEEP Valve configurations include:
- . 2.5 - 10.0 cm H2O Adjustable Valve
- 5.0 20.0 cm H2O Adjustable Valve .
- Fixed Valves at 2.5, 5.0, 7.5 and 10 cm H2O .
Indications for Use:
DISPO-BAG Manual Resuscitation Bag:
Single patient use manual resuscitator for use hospital, transport, emergency, and post hospital care to temporary ventilate a patient for the given body mass ranges of:
Infant: ≤ 10 Kq, Child: ≤ 23 Kg, Adult: >> 23 Kg
DISPO-BAG Manual Resuscitation Bag with Disposable PEEP Valve:
Single patient use manual resuscitator for use hospital, transport, emergency, and post hospital care to temporary ventilate a patient for the given body mass ranges of:
Infant: ≤ ≤ 10 Kg, Child: ≤ ≤ 23 Kg, Adult: > > 23 Kg
This manual resuscitator is supplied with a single patient use positive end expiratory pressure (PEEP) valve for use hospital, transport, emergency, and post hospital care to evaluate end lung pressure above atmospheric at the end of exhalation in constant and intermittent gas flow conditions.
Disposable PEEP Valve:
Single patient use device for use hospital, transport, emergency, and post hospital care for the elevation of lung pressure above atmospheric pressure at the end of exhalation.
Image /page/1/Figure/25 description: The image contains an address. The address is "87 Li-gong 2nd Road, Wu-jia, I-Lan 268, Taiwan". The address is located in the bottom center of the image. The rest of the image is blank.
- +866-(0)3-990-8618 Fax: +866-(0)3-990-8245
2
Image /page/2/Picture/0 description: The image shows the logo for Galer. The logo features the word "galer" in a bold, sans-serif font, with the letters slightly overlapping. Below the word "galer" is a thin line, and below that is some smaller text that is difficult to read due to the image quality. The logo has a modern and professional look.
Contraindications:
DISPO-BAG Manual Resuscitation Bag:
Contraindicated in individuals with a body mass of:
Infant: > > 10 Kg, Child: > > 23 Kg, Adult: > 10 Kg, Child: > > 23 Kg, Adult: 87 Li-gong 20d Road, Wu-jia, I-Lan 268 Taiwan
- +866-(0)3-990-8618 Fax: +866-(0)3-990-8245
Page 3 of 3
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure, rendered in black. The bird is facing right and has a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 5 2008
GaleMed Corporation C/O Mr. Thomas C. Loescher President A Plus Medical 5431 Avenida Encinas, Suite G Carlsbad, California 92008-4411
Re: K082092
Trade/Device Name: DISPO-BAG Manual Resuscitation Bag Disposable PEEP Valve DISPO-BAG Manual Resuscitation Bag with Disposable PEEP Valve Regulation Number: 21 CFR 868.5915 Regulation Name: Manual Emergency Ventilator Regulatory Class: II Product Code: BTM, BYE Dated: October 1, 2008 Received: October 2, 2008
Dear Mr. Loescher:
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. Loescher
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 (OS) 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) 276-0115. 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,
Chiu-Lien, Ph.D.
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
Enclosure
5
Indications for Use Statement
| 510(k) Number: | KO82092 |
|---|---|
| Device Name: | DISPO- BAG Manual Resuscitation Bag |
| Indications for Use: | Single patient use manual resuscitator for use hospital, transport, emergency, and post hospital care to temporary ventilate a patient for the given body mass ranges of: |
| Infant: $\leq$ 10 Kg, Child: $\leq$ 23 Kg, Adult: > 23 Kg |
Prescription Use Prescription Use
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)
L. Ahmed
(Divísion Sign-Øff) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K082092
6
Indications for Use Statement
| 510(k) Number: | KO82092 | ||
|---|---|---|---|
| Device Name: | DISPO- BAG Manual Resuscitation Bag with Disposable PEEP | ||
| Valve | |||
| Indications for Use: | Single patient use manual resuscitator for use hospital, transport, | ||
| emergency, and post hospital care to temporary ventilate a patient | |||
| for the given body mass ranges of: | |||
| Infant: ≤ 10 Kg, Child: ≤ 23 Kg, Adult: > 23 Kg |
This manual resuscitator is supplied with a single patient use positive
end expiratory pressure (PEEP) valve for use hospital, transport,
emergency, and post hospital care to evaluate end lung pressure
above atmospheric at the end of exhalation in constant and
intermittent gas flow conditions. | | |
| 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)
Ahmad
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K082092
7
Indications for Use Statement
- 510(k) Number: KO82092
- Device Name: Disposable PEEP Valve
- Indications for Use: Single patient use positive end expiratory pressure (PEEP) valve for use hospital, transport, emergency, and post hospital care to evaluate end lung pressure above atmospheric at the end of exhalation in constant and intermittent gas flow conditions.
Prescription Use (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)
signature
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K68