(97 days)
Empty bags made from ethyl vinyl acetate (EVA) film intended to contain total parenteral nutrition (TPN) solutions and compatible medications.
empty TPN bags made from EVA (ethylene vinyl acetate) plastic film in sizes ranging from 100mL to 3000mL in capacity
This document is a 510(k) premarket notification for a medical device submitted in 1997. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain a study that proves the device meets acceptance criteria.
The 510(k) summary focuses on demonstrating that the CharterMed TPN-EVA Bag is substantially equivalent to legally marketed predicate devices, rather than presenting a performance study with acceptance criteria.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies from the provided text.
Specifically, the document states:
- "The proposed CharterMed device is an empty bag made from ethylene vinyl acetate (EVA) plastic film. The bag is intended for containment of total parenteral nutrition solutions and is substantially equivalent in design and intended use to comparable products currently in commercial distribution."
- It then references two predicate devices (CharterMed's TOTM plasticized PVC container and Stedim Laboratories' EVA TPN Bag) to support the claim of substantial equivalence.
In summary, none of the requested information (points 1-9) about acceptance criteria and a study proving their fulfillment is present in the provided 510(k) submission. The document's purpose is to establish substantial equivalence for regulatory clearance, not to detail device performance against specific acceptance criteria through a clinical or performance study.
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K773103
NOV 24 1997
Image /page/0/Picture/1 description: The image shows the logo for CharterMed Inc. The logo features the company name in bold, black letters. A curved line partially surrounds the word "Charter" on the left, and a straight line underlines the entire name, adding a visual element to the design.
1805 Swarthmore Avenue Lakewood, New Jersey 08701
Telephone 732-901-9400
Fax 732-901-9405
| SECTION 1.0 - 510(k) SUMMARY | |
|---|---|
| CharterMed TPN/EVA Bag | |
| August 13, 1997 | |
| Page 1 of 2 | |
| Applicant Name | CharterMed Inc. |
| Address | 1805 Swarthmore AvenueLakewood, NJ 08701 |
| Contact Person | K. Alice Preville, DirectorQuality Assurance |
| Telephone | (732) 901-9400, extension 17 (voice mail) |
| FAX | (732) 901-9405extension 23 (operator) |
| Device Nomenclature | |
| a. Trade Name | CharterMed TPN-EVA Bags |
| b. Common Name | TPN bag |
| c. Classification Name | I.V. Container made of plastic used tohold a fluid mixture to be administeredto a patient through an intravascularadministration set (per 21 CFR 21 CFR880.5025). |
| Predicate Device | CharterMed Admixture Container for TotalParenteral Nutrition |
| Device Description | empty TPN bags made from EVA (ethylenevinyl acetate) plastic film in sizesranging from 100mL to 3000mL in capacity |
| Intended Use | to allow the admixture and holding oftotal parenteral nutritional (TPN)solutions prior to and duringintravascular administration to apatient. |
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Image /page/1/Picture/0 description: The image shows the logo for CharterMed Inc. The logo features the company name in a bold, sans-serif font. A curved line partially surrounds the word "Charter", and a straight line runs above the entire name, with another straight line below the entire name. The lines add a visual element to the logo.
1805 Swarthmore Avenue Lakewood, New Jersey 08701
Telephone 732-901-9400 Fax 732-901-9405
SECTION 1.0 - 510(k) SUMMARY CharterMed TPN/EVA Bag
August 13, 1997 Page 2 of 2 --------------------
Summary of the Technological Characteristics as compared to the Predicate Device
本の中のベーショーニュー・コーニュー・コーニュー・ニューニー・ニュー・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
The proposed CharterMed device is an empty bag made from ethylene vinyl acetate (EVA) plastic film. The bag is intended for containment of total parenteral nutrition solutions and is substantially equivalent in design and intended use to comparable products currently in commercial distribution. Two (2) examples are provided below.
CharterMed currently manufactures and markets an empty TPN container made from TOTM plasticized poly vinyl chloride (PVC) under the tradename MIXME. FDA granted substantial equivalency to the MIXME product line in 1990 under 510(k) K902079.
Stedim Laboratories of Aubagne, France received notification of substantial equivalency for a comparable device made from ethylene vinyl acetate (EVA) plastic film under 510(k) K911567. The device is referred to as the "Stedim TPN Bag - Dual E.V.A. empty container for parenteral admixtures designed for use with automated compounding devices".
Khelle
10/21/97
Date
K. Alice Preville, Director Quality Assurance
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. K. Alice Preville ·Director, Quality Assurance Chartermed, Incorporated 1805 Swarthmore Avenue Lakewood, New Jersey 08701
NOV 2 4 1997
K973103 Re : Chartermed TPN-EVA Bags Trade Name: Regulatory Class: II Product Code: KPE Dated: September 25; 1997 …………… Received: September 26, 1997
Dear Ms. Preville:
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 of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, qood 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 Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does
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Page 2 - Ms. Preville
not affect any obliqation 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 requlations.
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 leqally 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.qov/cdrh/dsmamain.html".
Sincerely yours
Timothy A. Ulatowski
Timothy A 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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K973/03
Page _ 1 _ of __ 1 _
510(k) Number (if known): __ K973103 _
Device Name: CharterMed TPN-EVA Bags
Indications for Use:
Empty bags made from ethyl vinyl acetate (EVA) film intended to contain total parenteral nutrition (TPN) solutions and compatible medications.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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J. de Tontadour Paris
(Division Sign-Off Division of Dental, Infection Control, and General Hospital Devices 510(k) Number .
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
Optional Format 1-2-96)
§ 880.5025 I.V. container.
(a)
Identification. An I.V. container is a container made of plastic or glass used to hold a fluid mixture to be administered to a patient through an intravascular administration set.(b)
Classification. Class II (performance standards).