(83 days)
Indicated as a single use, sterile device for use in I.V. therapy when an extended fluid path is required for administration.
Environment of use: Hospital, Emergency Medical Services, Home care settings wherever I.V. fluid administration may be indicated.
The Custom Assemblies Extension Set is a tubing set with various connectors, and accessories, such as drip chambers, infusion line filters, clamps, integral check valves, spikes, Y-site injection sits used as an extension of a fluid pathway for I.V. administration.
The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) submission for a medical device (Extension set/Intravascular Administration Set), focusing on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria.
Therefore, I cannot extract the requested information from the provided text.
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JAN - 4 2000
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Non-Confidential Summary of Safety and Effectiveness
| page 1 of 2 | |
|---|---|
| October 11, 1999 | |
| Custom Assemblies, Inc.306 E. Brown St.P.O. Box177Pine Level, NC 27568 | Tel - (919) 550-9620 |
| Fax - (919) 550-3817 | |
| Official Contact: | Jack Peacock - President |
| Proprietary or Trade Name: | Extension set |
| Common/Usual Name: | Intravascular Administration Set |
| Classification Name: | Intravascular Administration Set |
| Device: | Extension set |
| Predicate Devices: | R-Group - K940319The Kipp Group - I.V. Administration Set - K991932 |
1000 1000 1000 1000 1000 1000 Device Description: Noveller - A
The Custom Assemblies Extension Set is a tubing set with various connectors, and accessories, such as drip chambers, infusion line filters, clamps, integral check valves, spikes, Y-site injection sits used as an extension of a fluid pathway for I.V. administration.
| Intended Use: | |
|---|---|
| Indicated Use -- | Indicated as a single, use, sterile device for use in I.V. therapy when anextended fluid path is required for administration. |
| Environment of Use -- | Hospital, Emergency Services, Home settings, wherever I.V. administrationis utilized. |
Comparison to Predicate Device
Please change our mailing address to:
PO BOX 177 Pine Level, NC 27568
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Non-Confidential Summary of Safety and Effectiveness
page 2 of 2
October 11, 1999
| Attribute | Custom Assemblies | R. GroupK990319 | King GroupK991932 |
|---|---|---|---|
| Indicated for I.V. therapyand administration | Yes | Yes | Yes |
| Used as fluid path way | Yes | Yes | Yes |
| Single patient use | Yes | Yes | Yes |
| Environment where I.V therapyis indicated | Yes | Yes | Yes |
| Tubing of various lengths anddiameters | Yes | Yes | Yes |
| Connectors - luer fittings | Yes | Yes | Yes |
| Assembled with - dripchambers, clamps, infusion line filter,spikes, check valves, caps | Yes | Yes | Yes |
| Offered sterile | Yes | Yes | Yes |
| Tubing - PVC Class VI | Yes | Yes | Yes |
| Accessory componentsPolycarbonate, Polypropylene, PVC | Yes | Yes | Yes |
| None required under Section 514 | Yes | Yes | Yes |
Differences between 9ther Legally Marketed P Des 人 - 天津
There are no significant differences between the intended device and the predicates - R-Group - K940319 and The Kipp Group - K991932.
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Public Health Service
JAN - 4 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Custom Assemblies, Inc. c/o Mr. Paul E. Dryden on behalf Custom Assemblies, Inc. Promedic, Inc. 6329 W. Waterview Court McCordsville, Indiana 46055
Re: K993463 Trade Name: Intravascular Administration Set Class: II Product Code: FPA November 19, 1999 Dated: Received: November 23, 1999
Dear Mr. Dryden:
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, Drug, 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
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Page 2 - Mr. Dryden
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 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 requlation (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;
Timothy A. Ulatowski
Director
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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1 4434463
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Page 1 of 1
Pursuant to the Notice of February 6, 1996 regarding listing of Indications for Use on a separate sheet, the following is per that request.
| 510(k) Number: | (to be assigned) |
|---|---|
| Device Name: | I.V. Administration Sets |
| Intended Use: | Indicated as a single use, sterile device for use in I.V. therapy when an extended fluid path is required for administration. |
| Environment of use: | Hospital, Emergency Medical Services, Home care settings wherever I.V. fluid administration may be indicated. |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per CFR 801.109)
or
Over-the-counter use
Julien Laurentie
് Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510(k) Number ________________________________________________________________________________________________________________________________________________________________
2-5R
§ 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.