(27 days)
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Not Found
No
The description focuses on resistive heating, temperature monitoring, and fault detection based on predefined conditions, with no mention of learning or adaptive algorithms.
Yes
The device is intended to prevent hypothermia by warming fluids administered to patients, which is a therapeutic intervention.
No
The device is a fluid warmer, intended for warming blood and intravenous solutions. Its function is to prevent hypothermia by heating fluids, not to diagnose medical conditions or provide diagnostic information about a patient's health. While it monitors fluid temperature and detects faults, these functions are for safe operation of the warming process, not for diagnostic purposes.
No
The device description clearly outlines three hardware components: a heater unit, a power module, and a disposable set. It also describes physical processes like resistive heating and fluid flow.
Based on the provided text, the Belmont buddy™ Fluid Warmer is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to warm blood, blood products, and intravenous solutions prior to administration to a patient. This is a therapeutic or supportive function, not a diagnostic one.
- Device Description: The device warms fluids flowing through it and monitors temperature and flow. It does not analyze biological samples or provide information about a patient's health status.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) or providing diagnostic information.
- Focus on Fluid Preparation: The device's function is solely related to preparing fluids for infusion into the body.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Belmont buddy™ Fluid Warmer does not perform any of these functions.
N/A
Intended Use / Indications for Use
The buddy™ Fluid Warmer intended use is for warming blood, blood products and intravenous solution prior to administration. It is intended to be used by healthcare professionals in clinical environments to prevent hypothermia.
Product codes
81BSB
Device Description
The Belmont buddy™ Fluid Warmer is a portable in-line blood and fluid warmer. It consists of three components, a heater unit, a power module and exchanger set. The heater unit and displays alarm and status messages, and a power module which powers the heater unit. The heating technology used is resistive heating of two plates within the heater unit.
The buddy™ Fluid Warmer warms intra-venous fluids, including blood and blood products, to physiological temperature, and monitors fluid temperature. It also senses lack of flow, or empty set, and a number of internal fault conditions, such as, electrical connection to the heater, and failure to heat. The device stops heating and alarms if an alarm or fault condition occurs. The device provides the user with alarm, alarm message, temperature, and other operating information via a bright alphanumeric display.
The sterile disposable set is placed in-line between a standard IV line at its input and the IV infusion set at its output. The input can come from a bag or supplied with other clamp and drip chamber, external to the device and not supplied by Belmont Instrument Corp.
The device is intended for low flow applications where the flow rate is 6 liter/hour (100 ml/min) or less.
This premarket application describes a modification to the disposable set.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
healthcare professionals in clinical environments
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
In order to verify performance of the Belmont buddy™ Fluid Warmer in support of substantial equivalence, the following tests were carried out:
a. Verify the ability of the system to warm cold fluids to physiological temperature.
b. Verify the ability of the system to protect the patient and to detect and alarm at unsafe or ineffective operating conditions.
Conclusion: The modified Belmont buddy™ Fluid Warmer Blood/Fluid Warmer is substantially equivalent to the buddy™ Fluid Warmer which received 510(k) approval on July 2, 2003. Both systems have the same intended use, and are capable of heating blood products or intravenous fluids to physiological temperature. Both systems perform as intended according to the specifications of the device.
Key Metrics
Not Found
Predicate Device(s)
Belmont Instrument Corporation Microheater marketed as Belmont buddy™ Fluid Warmer.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.9205 Blood and plasma warming device.
(a)
Nonelectromagnetic blood or plasma warming device —(1)Identification. A nonelectromagnetic blood and plasma warming device is a device that warms blood or plasma, by means other than electromagnetic radiation, prior to administration.(2)
Classification. Class II (performance standards).(b)
Electromagnetic blood and plasma warming device —(1)Identification. An electromagnetic blood and plasma warming device is a device that employs electromagnetic radiation (radiowaves or microwaves) to warm a bag or bottle of blood or plasma prior to administration.(2)
Classfication. Class III (premarket approval).(c)
Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval for the device described in paragraph (b)(1). See § 864.3.
0
Ko52547
OCT 1 3 2005
Image /page/0/Picture/2 description: The image shows the logo for Belmont Instrument Corporation. The logo features a stylized letter "B" followed by the text "elmont Instrument Corporation" in a serif font. Below the company name is the tagline "Creating a New Standard of Care".
Attachment 4
Registered in Accordance with ISO 13485
Premarket Notification 510(k) Summary of Safety and Effectiveness [As Required By 21 CFR 807.92(a)]
-
Belmont Instrument Corporation 1. Submitter & Manufacturing Site: 780 Boston Road Billerica, MA 01821
Establishment Registration Number: 1219702 -
Uraiwan P. Labadini, Quality Assurance/Regulatory Affairs 2. Contact Person: Manager
(978) 663-0212 Ext. 28 Fax: (978) 663-0214 Telephone: -
- Belmont buddy™ Fluid Warmer Trade Name:
-
Nonelectromagnetic Blood or Fluid Warming Device 4. Common name:
-
Classification name: Blood/Fluid Warmer 5.
-
- Product Code: 81BSB Classified as a Class II device per Federal Register July, 1978. Device Class:
-
- Legally marketed predicate device to which substantial equivalence is claimed: Belmont Instrument Corporation Microheater marketed as Belmont buddy™ Fluid Warmer.
1
| Attachment 4 | Belmont Instrument Corporation | |
|---|---|---|
| Page 2 of 3 |
- Brief Description: The Belmont buddy™ Fluid Warmer is a portable in-line blood 8. and fluid warmer. It consists of three components, a heater unit, a power module and fidid warmor. It setter unit and displays alarm and status messages, and a which powere the houter and exchanger set. The heating technology used is resistive heating of two plates within the heater unit.
The buddy™ Fluid Warmer warms intra-venous fluids, including blood and blood products, to physiological temperature, and monitors fluid temperature. It also products, to priyoner or empty set, and a number of internal fault conditions senses fack of the how, or emprical connection to the heater, and failure to heat. The device stops heating and alarms if an alarm or fault condition occurs. The The dovice the user with alarm, alarm message, temperature, and other operating information via a bright alphanumeric display.
The sterile disposable set is placed in-line between a standard IV line at its input and r re stemo diopodable von is V infusion set at its output. The input can come from a a asor Supplied outher clamp and drip chamber, external to the device and not supplied by Belmont Instrument Corp.
The device is intended for low flow applications where the flow rate is 6 liter/hour (100 ml/min) or less.
This premarket application describes a modification to the disposable set.
- Intended Use: The buddy™ Fluid Warmer intended use is for warming blood, blood 9. intondou ood. The banus solution prior to administration. It is intended to be used products and intraressionals in clinical environments to prevent hypothermia.
- Summary of the technological characteristics of the Belmont buddy™ Fluid 10. Warmer:
The heater unit is powered with 15 V pulsed DC which is derived from 120 or 230 The Heater anit is powerful with T. The temperature of the infused fluids, visual and audible alarms, and other performance characteristics of the heater unit are audible alarmo, and other polisposable set consists of a molded frame to which controlled chectronically. The side and a microporous membrane is bonded to the a plastic film is bonded to one blas shas a sterile, non-pyrogenic fluid path, and is for single-patient use only.
2
| Attachment 4 | Belmont Instrument Corporation |
|---|---|
| Page 3 of 3 |
Summary of Nonclinical Tests and Results 11.
In order to verify performance of the Belmont buddy™ Fluid Warmer in support of substantial equivalence, the following tests were carried out:
- Verify the ability of the system to warm cold fluids to physiological temperature. a.
- Verify the ability of the system to protect the patient and to detect and alarm at b. unsafe or ineffective operating conditions.
- Conclusion: The modified Belmont buddy™ Fluid Warmer Blood/Fluid Warmer is 12. substantially equivalent to the buddy™ Fluid Warmer which received 510(k) approval on July 2, 2003. Both systems have the same intended use, and are capable of heating blood products or intravenous fluids to physiological temperature. Both systems perform as intended according to the specifications of the device.
3
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name arranged in a circular pattern around a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff entwined by two snakes and topped with wings.
Public Health Service
OCT 1 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Uraiwan P. Labadini Quality Assurance/Regulatory Affairs Manager Belmont Instrument Corporation 780 Boston Road Billerica, Massachusetts 01821
Re: K052547
Trade/Device Name: BELMONT BUDDY FLUID WARMER Regulation Number: 21 CFR 864.9205 Regulation Name: Blood and plasma warming device Regulatory Class: II Product Code: BSB Dated: September 14, 2005 Received: September 16, 2005
Dear Mr. Labadini:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rowed your 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 for use stated in the encreativent of 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 r ou may, cherefore, mains of the Act include requirements for annual registration, listing of general volurely provision 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 rr your device to such additional controls. Existing major regulations affecting your device can may be subject to back as a sateral 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. Labadini
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 or cary i 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 Of R Part 877) havenses (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) I ms lotter will and in your 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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other Ectorers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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
510(k) Number (if known): __________K052547
Belmont buddy™ Fluid Warmer Device Name:
Indications For Use:
buddy™ Fluid Warmer intended use is for warming blood, blood products and intravenous solution prior to administration. It is intended to be used by healthcare professionals in clinical environments to prevent hypothermia.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/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)
Anthony D. nunez
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: _ KyS2547
Page 1 of _ 1