(87 days)
Not Found
No
The device description and performance studies focus on the physical properties and safety of a container for intravenous solutions, with no mention of AI or ML.
No
The device is an empty container used to store intravenous solutions, not to treat a disease or condition.
No
The device is an empty container used to store intravenous solution for administration to patients. Its function is to hold fluids, not to diagnose medical conditions or analyze patient data.
No
The device description clearly outlines physical components like chambers, ports, and tubing, indicating it is a hardware device for holding and administering intravenous fluids.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to store intravenous solution for administration to a patient. This is a direct interaction with the patient's body for therapeutic purposes (delivering fluids and potentially medication).
- Device Description: The description details a container for holding and administering fluids intravenously. It mentions fill ports, injection ports, and a spike port for connecting to administration tubing. These are all components related to delivering substances into the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis on bodily specimens.
The device described is a container for intravenous solutions, which falls under the category of medical devices used for drug delivery or fluid administration, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
An Empty Container with sterile fluid pathway used to store intravenous solution for administration to patient. Medication transfer in and out of the container is done using aseptic technique.
Product codes
KPE
Device Description
Acta Medical Empty EVA Solution Container is designed to hold intravenous fluid in a single chamber or in dual chambers separated by a separating partition. Empty EVA Solution Container and Empty EVA Dual Chamber Solution Container has fill ports to fill single and dual chambers, latex free injection port for additions of injectable additives and a spike port to connect intravascular administration tubing. The fill port tubing has a sealing clamp to secure the contents during storage post filling and prior to their administration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Acta Medical EVA Mixing Container has been subjected to a variety of tests to demonstrate safety of the proposed device. These tests include biocompatibility, material strength, physical and chemical testing, leak testing and stability testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
510k Summary of Safety and Effectiveness As required by Section 21 CFR 807.92€
JUL 1 3 2012
17116
Acta Medical
Date Submitted: Submitted By:
March 26, 2012 Acta Medical 15 Minneakoning Road, Suite 203 Flemington. NJ 08822 908-399-0279 Fax(908)-788-2788 Contact email: brewerjh@comcast.net
Submitter Contact:
John Brewer Acta Medical 4 Nevius Drive, Flemington, NJ 08822 brewerjh@comcast.net Tel:908-399-0279 Fax:908-788-2788
Common Name of Device: Empty EVA Solution Container
| Predicate Device: | EVA Empty Solution Container (K030888)
Churchill Dual Chamber Empty Container (K041038) |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Panel: | General Hospital and Personal Use |
| Product Code: | KPE |
| Device Classification: | IV Container, Class II, 21CFR880.5025 |
| Manufacturing Location: | Yangzhou Wei De Li Trade Co. Ltd.
Li Xin Bridge
Tougiao Township. Yangzhou City, Jiangsu Province.
China
Tel: +86-514-87897887 Fax: +86-514-87889967 |
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page 2 of 2
Name & Model Numbers of Devices:
-
- ACTINF250. Empty EVA Solution Container 250ml
-
- ACTINF1000, Empty EVA Solution Container 1000ml
-
- ACTINF2000, Empty EVA Solution Container 2000ml
-
- ACTINF3000, Empty EVA Solution Container 3000ml
-
- ACTINF750D, Empty EVA Dual Chamber Solution Container 750ml
-
- ACTINF1500D, Empty EVA Dual Chamber Solution Container 1500ml
-
- ACTINF3000D, Empty EVA Dual Chamber Solution Container 3000ml
Device Description:
Acta Medical Empty EVA Solution Container is designed to hold intravenous fluid in a single chamber or in dual chambers separated by a separating partition. Empty EVA Solution Container and Empty EVA Dual Chamber Solution Container has fill ports to fill single and dual chambers, latex free injection port for additions of injectable additives and a spike port to connect intravascular administration tubing. The fill port tubing has a sealing clamp to secure the contents during storage post filling and prior to their administration.
Device Intended Use: Empty EVA Solution Container
An Empty Container with sterile fluid pathway used to store intravenous solution for administration to patient. Medication transfer in and out of the container is done using aseptic technique.
Substantial Equivalence:
Acta Medical Empty EVA Solution Container is substantially equivalent to the predicate devices. Acta Medical Empty EVA Solution Container, device design, component materials, indication for use, SAL are substantially equivalent to the predicate devices.
Acta Medical EVA Mixing Container has been subjected to a variety of tests to demonstrate safety of the proposed device. These tests include biocompatibility, material strength, physical and chemical testing, leak testing and stability testing.
2
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 tail feathers, representing the department's commitment to promoting health, well-being, and human services. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The logo is simple and recognizable, conveying the department's role in serving the American people.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Aaron Compton Acta Medical LLC 929 Arbor Downs SR Plano, Texas 75023
JUL 1 3 2012
Re: K121161
Trade/Device Name: Empty EVA Solution Container Regulation Number: 21 CFR 880.5025 Regulation Name: I.V. Container Regulatory Class: II Product Code: KPE Dated: March 26, 2012 Received: April 17, 2012
Dear Mr. Compton:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above 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 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) 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 general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2- Mr. Compton
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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
For
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Anthony D. Watson, B.S., M.S., M.B.A.
Enclosure
4
(12116
Indications for Use
510(k) Number (if known): _
Device Name: _____ Empty EVA Solution Container
Indications For Use: An Empty Container with sterile fluid pathway used to store intravenous solution for administration to patient. Medication transfer in and out of the container is done using aseptic technique.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ll C. Ch. 7/13/12
(Division Sign-Off) (Division Sign-Sthesiology, General Hospital Infection Control, Dental Devices
Page 1 of 1
510(k) Number: K121161