(106 days)
The ClearStar pump can be used for adult and pediatric patients provided the patients can tolerate a feeding range within the pump operational specifications. Those specifications are:
-
- The flow rate range is 1-300 ml/hr in I mL/hr increments
-
- The flow rate accuracy is ± 10% or ± 0.5 mL/hr, whichever is greater
-
- The occlusion pressure limit is 26-30 psi.
If these specifications are not appropriate for a given patient, the ClearStar pump should not be used.
- The occlusion pressure limit is 26-30 psi.
The ClearStar pump raises no new questions of safety or effectiveness above those currently associated with enteral feeding pumps. The operator's manual for the ClearStar pump provides warnings regarding volume sensitive patients similar to those found in the operating manuals of the Companion and Quantum enteral feeding pumps. The pump's automatic clog clearing function has been designed to ensure that the nominal pressure exerted on a clog is in the 26 to 30 psi range. Additionally, to ensure that the patient is not underfed, the pump, if unsuccessful in clearing a clog before ten (10) minutes have elapsed, will alarm occlusion. Finally, the pump can only be in the clog clearing mode a maximum of twenty (20) minutes or ten times in any consecutive four (4) hour period. If twenty (20) minutes or ten times are exceeded, the pump will alarm occlusion.
The provided text describes the "ClearStar Enteral Nutrition Pump" and its safety and effectiveness. It outlines performance specifications and how these were designed and verified, but it does not contain information about a study proving the device meets acceptance criteria in the context of a medical AI device submission.
Therefore, I cannot fulfill your request for details on a study proving a device meets acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information.
The document is a 510(k) summary for a medical device (an enteral feeding pump), which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This process primarily focuses on comparing the new device's indications for use and technological characteristics to an existing device, and verifying that it raises no new questions of safety or effectiveness. It does not typically involve the type of clinical performance studies and ground truth establishment methodologies that are relevant for AI/ML-based medical devices as outlined in your prompt's questions.
Here's a breakdown of what can be extracted regarding acceptance criteria and performance based on the provided text, but it's important to understand this is not in the context of an AI/ML study:
ClearStar Enteral Nutrition Pump: Acceptance Criteria and Reported Performance
The document describes the design and expected performance characteristics of the ClearStar pump, particularly concerning its clog-clearing function and pressure limits.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Design Goal / Specification) | Reported Device Performance (as described) |
|---|---|
| Nominal pressure exerted on a clog during automatic clog clearing | 26 to 30 psi range |
| Maximum time for unsuccessful clog clearing before alarming occlusion | 10 minutes |
| Maximum duration in clog clearing mode within any consecutive 4-hour period | 20 minutes |
| Maximum number of times in clog clearing mode within any consecutive 4-hour period | 10 times |
| Pressure build-up during occlusion relative to feeding tube pressure limit (40 psi) | Maintained safely below the maximum pressure specification of the feeding tubes (implied < 40 psi) |
| Flow rate range | 1-300 ml/hr |
| Flow rate increments | 1 mL/hr |
| Flow rate accuracy | ± 10% or ± 0.5 mL/hr, whichever is greater |
| Occlusion pressure limit (as stated in Indications for Use) | 26-30 psi |
Information Not Available / Applicable from the Provided Text:
- 2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable for this type of device submission. Performance is based on engineering design and bench testing, not clinical data in the sense of a test set for an algorithm.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an enteral pump's mechanical function is based on physical measurements and engineering specifications, not expert interpretation of data.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable, as this is not an AI device.
- 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is not an AI device.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the pump's mechanical characteristics, the "ground truth" would be established via engineering measurements, calibration, and pressure/flow testing against established physical standards and design specifications.
- 8. The sample size for the training set: Not applicable, as this is not an AI device.
- 9. How the ground truth for the training set was established: Not applicable, as this is not an AI device.
In summary, the provided document describes the design features and performance specifications of a mechanical medical device (an enteral pump) as part of a 510(k) submission, emphasizing its substantial equivalence to predicate devices and inherent safety features. It does not provide the type of study data, methodologies, or "ground truth" definitions relevant to an AI/ML device assessment.
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AUG 1 3 1998
K98/1541
106
SUMMARY OF SAFETY and EFFECTIVENESS FOR THE CLEAR STAR PUMP
The ClearStar pump raises no new questions of safety or effectiveness above those currently associated with enteral feeding pumps. The operator's manual for the ClearStar pump provides warnings regarding volume sensitive patients similar to those found in the operating manuals of the Companion and Quantum enteral feeding pumps.
The pump's automatic clog clearing function has been designed to ensure that the nominal pressure exerted on a clog is in the 26 to 30 psi range. Additionally, to ensure that the patient is not underfed, the pump, if unsuccessful in clearing a clog before ten (10) minutes have elapsed, will alarm occlusion. Finally, the pump can only be in the clog clearing mode a maximum of twenty (20) minutes or ten times in any consecutive four (4) hour period. If twenty (20) minutes or ten times are exceeded, the pump will alarm occlusion.
Product literature for enteral feeding tubes (nasogastric and gastrostomy) cautions not to use a pump or syringe that causes pressures to build beyond 40 psi This warning is pressures above 40 psi can cause med-port plugs to separation of the feeding set from the feeding tube. Pressure build-up with the ClearStar pump during occlusion is maintained safely below the maximum pressure specification of the feeding tubes.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 3 1998
Mr. J. Paul Hanson Vice President Metabolic & Diagnostic Division Frantz Medical 7740 Metric Drive Mentor, Ohio 44060
Re : K981541 ClearStar Enteral Nutrition Pump Trade Name: Requlatory Class: II Product Code: LZA Dated: June 4, 1998 Received: June 5, 1998
Dear Mr. Hanson:
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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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
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Page 2 - Mr. Hanson
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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) 594-4692. 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,
S. Butman for
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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510(k) Number (if known): _(1981541
Device Name: ClearStar Enteral Nutrition Pump
Indications For Use:
The ClearStar pump can be used for adult and pediatric patients provided the patients can tolerate a feeding range within the pump operational specifications. Those specifications are:
-
- The flow rate range is 1-300 ml/hr in I mL/hr increments
-
- The flow rate accuracy is ± 10% or ± 0.5 mL/hr, whichever is greater
-
- The occlusion pressure limit is 26-30 psi.
If these specifications are not appropriate for a given patient, the ClearStar pump should not be used.
Precautions
All enteral pumps have the potential to bolus-feed or over deliver, which is an important consideration in feeding volume-sensitive patients. In these patients, a volume of product no more than four times the hourly feeding rate should be hung.
Confirm proper placement and function.
Confirm proper placement and function of patient's enteral feeding tube (nasogastric, jejunostomy, gastrostomy, etc.), and verify the following before initiating feeding:
-
- A ClearStar Pump Set is being used.
-
- Cassette is properly seated in pump.
-
- When on AC power, pump is fully seated in charger.
-
- Flow rate is set at the prescribed ml/hr.
-
- Pump dial is turned to RUN.
Note: The Power Supply Cord is the DISCONNECT DEVICE
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| -- | -------------------------------------------------------- | -- |
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801.109) |
| (Division Sign-Off) | |
|---|---|
| -- | --------------------------------------- |
Division of Dental, Infection Control,
and General Hospital Devices
| 510(k) Number | K981541 |
|---|---|
| --------------- | --------- |
| Over-The-Counter Use | |
|---|---|
| (Optional Format 1-2-96) |
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).