(290 days)
Not Found
No
The device description and performance studies focus on physical filtration and humidification properties, with no mention of AI or ML.
Yes
The device is designed to reduce bacterial/viral transmission, reduce the loss of patient heat and humidity, and provide passive humidification and heated, humidified air to the patient, all of which are direct interventions for patient well-being and health maintenance.
No
The device is described as a heat and moisture exchanger filter (HMEF) used for passive humidification and preventing bacterial/viral transmission in breathing circuits. While it has a port for CO2 monitoring, its primary function is not diagnostic, but rather therapeutic/supportive.
No
The device description clearly states it is a physical HMEF containing HME paper and an electrostatic filter pad encased in a plastic housing. It also mentions physical connectors and a luer lock port. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Inter-Therm Mini Pediatric HMEF is a device used in a breathing circuit to filter air and manage heat and humidity for patients undergoing mechanical ventilation or anesthesia. It directly interacts with the patient's respiratory system, not with specimens taken from the patient.
- Intended Use: The intended use clearly states it's for use at patient connections in a breathing circuit to reduce bacterial/viral transmission and manage heat/humidity. This is a therapeutic/supportive function, not a diagnostic one.
- Device Description: The description details its components (HME paper, electrostatic filter) and how it functions within the breathing circuit. There is no mention of analyzing biological specimens.
- Performance Studies: The performance studies focus on physical characteristics and filtration efficiency related to its function in the breathing circuit, not on diagnostic accuracy or analysis of biological samples.
Therefore, the Inter-Therm Mini Pediatric HMEF is a medical device used in respiratory support, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Inter-Therm Mini Pediatric HMEF Sterile is for use at the patient connections. The device is to be attached between the breathing circuit and patient connection. It is designed to reduce bacterial/viral transmission between the patient and equipment and to reduce the loss of patient heat and humidity. The filter is for single patient use only and therefore must be disposed of after a single patient usage and/or after its maximum duration of use at 24 hours. The device is a single use device that is required to be changed daily when used with devices (i.e. long-term ventilators) that are design to have patient body contact between 24 hours to
§ 868.5260 Breathing circuit bacterial filter.
(a)
Identification. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three faces in profile, stacked on top of each other. The faces are oriented to the right and are connected to form a single, flowing shape. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 12, 2015
Intersurgical® Inc. Mr. Michael Zalewski Vice President, RA/QA/CS 417 Electronics Parkway Liverpool NY, 13088
Re: K141087
Trade/Device Name: Product # 1331030S-Inter-Therm Mini Pediatric HMEF sterile Product # 1332030S-Inter-Therm Mini Pediatric angled HMEF sterile Regulation Number: 21 CFR 868.5260 Regulation Name: Filter, Bacterial, Breathing Circuit Regulatory Class: II Product Code: CAH Dated: January 12, 2015 Received: January 13, 2015
Dear Mr. Zalewski:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
1
Page 2 - Mr. Zalewski
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Section 4 Indications for Use Statement
510(k) Number (if known): K141087
Device Name:
Product # 1331030S - Inter-Therm Mini Pediatric HMEF sterile Product # 1332030S - Inter-Therm Mini Pediatric angled HMEF sterile
Indications For Use: The Inter-Therm Mini Pediatric HMEF Sterile is for use at the patient connections. The device is to be attached between the breathing circuit and patient connection. It is designed to reduce bacterial/viral transmission between the patient and equipment and to reduce the loss of patient heat and humidity. The filter is for single patient use only and therefore must be disposed of after a single patient usage and/or after its maximum duration of use at 24 hours. The device is a single use device that is required to be changed daily when used with devices (i.e. long-term ventilators) that are design to have patient body contact between 24 hours to 99.99 |
| Tapers | PASS | PASS | ISO standard 15mm
and 22mm |
| Ageing: 5 months | PASS | PASS | N/A |
| Ageing: 5 years | PASS | PASS | N/A |
| Materials: | | | |
| HMEF housing | Acrylonitrile Butadiene
Styrene | Acrylonitrile Butadiene
Styrene | - |
| Electrostatic filter | Polypropylene-based
fiber blend | Polypropylene-based
fiber blend | - |
| HME paper | Cellulose-based paper | Cellulose-based paper | - |
| Retainable luer port
cap | Thermoplastic
Elastomer with green
color | Thermoplastic Elastomer
with green color | - |
| Energy
Used/Delivered: | Warm humidified air is
extracted from
expiratory air and
delivered to the
patient's inspiratory air. | Warm humidified air is
extracted from expiratory
air and delivered to the
patient's inspiratory air. | Warm humidified air is
extracted from
expiratory air and
delivered to the
patient's inspiratory
air. |
| Compatibility: | Designed for use with
breathing systems,
elbows, catheter
mounts and CO2
monitoring lines | Designed for use with
breathing systems,
elbows, catheter mounts
and CO2 monitoring
lines | Designed for use with
breathing systems,
elbows, catheter
mounts and CO2
monitoring lines |
| Biocompatibility: | | | |
| Sterility: | Sterile | Sterile | Clean |
| Standards Met: | | | |
| HME | ISO 9360-1:1992 | ISO 9360-1:1992 | ISO 9360-1:1992 |
6
Section 5 510(k) Summary of Safety and Effectiveness Device Comparison Table
7
Section 5 510(k) Summary of Safety and Effectiveness Device Comparison Table
| Characteristic
Compared | Inter-Therm Mini
Pediatric HMEF sterile
1331030S | Inter-Therm Mini
Pediatric angled HMEF
sterile 1332030S | DARTM Infant -
Pediatric
Electrostatic Filter
HME (Small)
355U5430
K941381 |
|----------------------------|--------------------------------------------------------|---------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Conical Connector
ends | ISO 5356-1:2004 | ISO 5356-1:2004 | ISO 5356-1:2004 |
| Luer lock connectors | ISO 594-2:1998 | ISO 594-2:1998 | - |
Summary of Testing:
Nonclinical tests submitted to demonstrate substantial equivalence for moisture return, resistance to flow, weight, tapers and filtration efficiency. All materials used in the breathing filters have been evaluated according to tests outlined in ISO 10993-1 and meet the requirements of Bluebook Memo, General Program Memorandum G95-1 biocompatibility testing for cytotoxicity, sensitization, and irritation. The connectors meet the requirements of Anesthetic and respiratory equipment - conical connectors: Part 1: Cones and Sockets ISO 5356-1:2004. ISO 594-2:1998 Conical Fittings with a Luer Taper and Heat and Moisture Exchangers ISO 9360-1:1992.
Substantial Equivalence:
Intersurgical Incorporated has demonstrated that the proposed device is as safe and effective as the predicate device. It is considered to be substantially equivalent to the currently marketed predicate device which has been previously reviewed for market clearance by the FDA.
K141087 Premarket Notification [510(k)] Number