(27 days)
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.
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 a disposable set. The power module powers the heater unit and displays alarm and status messages, and a disposable set which is placed in the heater unit and through which the fluid flows. 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 a standard IV infusion set at its output. The input can come from a bag or supplied via a standard 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.
The provided document is a 510(k) Premarket Notification for the Belmont buddy™ Fluid Warmer. It describes modifications to an existing device and claims substantial equivalence to its predicate device. However, it does not contain detailed acceptance criteria, specific performance metrics, or a formal study design that would allow for a comprehensive table of acceptance criteria and reported device performance.
The document states that "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." It concludes that "Both systems perform as intended according to the specifications of the device." However, it does not explicitly list these specifications or the quantitative results of the verification tests.
Therefore, I cannot provide a table of acceptance criteria and reported device performance with numerical values, nor can I answer many of the specific questions about sample size, ground truth, or MRMC studies, as this information is not present in the provided text.
Here's a breakdown of what can be inferred or directly stated from the document, and where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria (Inferred from testing goals):
- Ability to warm cold fluids to physiological temperature.
- Ability to protect the patient and to detect and alarm at unsafe or ineffective operating conditions.
- Reported Device Performance:
- The document states that the device "performs as intended according to the specifications of the device" and is "capable of heating blood products or intravenous fluids to physiological temperature." No specific numerical performance values (e.g., target temperature range, alarm thresholds, accuracy) are provided in this summary.
2. Sample size(s) used for the test set and the data provenance
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The tests were carried out by the manufacturer to verify performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. The "ground truth" here would be the device's ability to meet its engineering and functional specifications, which would be assessed through objective testing and measurement, not expert interpretation of outputs in the clinical sense.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. Performance was verified against device specifications and functional requirements through testing, not through expert adjudication of an output or diagnosis.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a fluid warmer, not a diagnostic AI system that would assist human readers in interpreting data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: Yes, in a sense. The described "verification tests" would evaluate the device's ability to perform its warming and safety functions independently, without a human "in-the-loop" influencing its core operational performance. However, this is not an "algorithm-only" performance in the context of AI, but rather a functional device performance.
7. The type of ground truth used
- Type of Ground Truth: The "ground truth" for this device's performance would be engineering specifications and functional requirements related to temperature regulation, alarm conditions, and fluid flow detection, verified through objective measurements and testing. This is not "expert consensus, pathology, or outcomes data" in the typical medical imaging/AI context.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This device is a hardware fluid warmer with embedded controls, not a machine learning or AI system that requires a "training set" in the conventional sense. Its "training" would be its design, calibration, and manufacturing processes.
9. How the ground truth for the training set was established
- How Ground Truth for Training Set Established: Not applicable, as there is no "training set" for this type of device. The specifications and functional requirements are established through engineering design, regulatory standards, and intended use.
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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.
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| 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.
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| 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.
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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.
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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
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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
§ 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.