(138 days)
For the delivery of I.V. solutions by or on the order of a physician or other licensed practitioner.
PROTOS® I.V. Administration Set (15 Drops/ML) and (60 Drops/ML)
The provided text is a 510(k) premarket notification letter from the FDA regarding an IV administration set. This type of document does not typically contain the detailed acceptance criteria and study results that would be used to prove a device meets those criteria.
510(k) clearances are primarily based on demonstrating substantial equivalence to an already legally marketed predicate device, rather than detailed performance studies proving specific acceptance criteria. The letter confirms that Globe Enterprises, Incorporated's PROTOS® I.V. Administration Set is substantially equivalent to existing devices.
Therefore, for your request, I must state that the provided document does not contain the information necessary to fulfill items 1 through 9.
Specifically:
- A table of acceptance criteria and the reported device performance: Not present. The letter is a regulatory approval, not a performance report.
- Sample sized used for the test set and the data provenance: Not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
- Adjudication method: Not present.
- 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. This is not an AI/imaging device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/imaging device.
- The type of ground truth used: Not present.
- The sample size for the training set: Not applicable. This device is not an algorithm requiring a training set.
- How the ground truth for the training set was established: Not applicable.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the circumference. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Stephen Y. Jan Product Manager Globe Enterprises, Incorporated 4930 Campbell Road Houston, Texas 77041
DEC 17 1997
Re : K972854 PROTOS® I.V. Administration Set (15 Drops/ Trade Name: ML) and (60 Drops/ML) Requlatory Class: II Product Code: FPA October 28, 1997 Dated: Received: October 29, 1997
Dear Mr. Jan:
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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does
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Page 2 Mr. Jan
not affect any obligation you might have under sections 531 through 542 of 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) 594-4618. 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/
V Ulatowski Timothy A. Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
ਾ ਕੁੱਝ ਕਰਨ ਦੇ ਸਾਲ ਦੇ ਸੰਗਰਾ ਸੀ। ਉਸ ਦੀ ਸਾਹਿਤ ਸੀ। ਉਸ ਦੀ ਸਾਹਿਤ ਸੀ। ਉਸ ਦੀ ਸਾਹਿਤ ਸੀ। ਉਸ ਦੀ ਸਾਹਿਤ ਸੀ। ਉਸ ਦੀ ਸਾਹਿਤ ਸੀ। ਉਸ ਦੀ ਸਾਹਿਤ ਸੀ। ਉਸ ਦੀ ਸਾਹਿਤ ਸੀ। ਉਸ ਦੀ ਸਾਹਿਤ ਸੀ। ਉਸ ਦੀ ਸਾਹਿਤ ਸੀ
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Stephen Y. Jan Product Manager Globe Enterprises, Incorporated 4930 Campbell Road Houston, Texas 77041
DEC 17 1997
Re : K972854 PROTOS® I.V. Administration Set (15 Drops/ Trade Name: ML) and (60 Drops/ML) Requlatory Class: II Product Code: FPA October 28, 1997 Dated: Received: October 29, 1997
Dear Mr. Jan:
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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does
{3}------------------------------------------------
Page 2 Mr. Jan
not affect any obligation you might have under sections 531 through 542 of 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) 594-4618. 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/
V Ulatowski Timothy A. Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
ਾ ਕੁੱਝ ਕਰਨ ਦੇ ਸਾਲ ਦੇ ਸੰਗਰਾ ਸੀ। ਉਸ ਦੀ ਸਾਹਿਤ ਸੀ। ਉਸ ਦੀ ਸਾਹਿਤ ਸੀ। ਉਸ ਦੀ ਸਾਹਿਤ ਸੀ। ਉਸ ਦੀ ਸਾਹਿਤ ਸੀ। ਉਸ ਦੀ ਸਾਹਿਤ ਸੀ। ਉਸ ਦੀ ਸਾਹਿਤ ਸੀ। ਉਸ ਦੀ ਸਾਹਿਤ ਸੀ। ਉਸ ਦੀ ਸਾਹਿਤ ਸੀ। ਉਸ ਦੀ ਸਾਹਿਤ ਸੀ
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Image /page/4/Picture/0 description: The image shows a sequence of handwritten characters and numbers. The sequence starts with the letter 'K', followed by the numbers '972854'. The characters are written in a cursive style, with varying stroke thicknesses.
510(k) Number (if known):_____________
Device Name: PROTOS® I.V. Administration Set
Indications For Use:
For the delivery of I.V. solutions by or on the order of a physician or other licensed practitioner.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Patricia Cusimite
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K972854
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.