(36 days)
Not Found
No
The device description and performance studies focus on the mechanical and physical properties of a syringe, with no mention of AI or ML capabilities.
No
The device is described as an oral/enteral syringe used to measure and administer medication and nutrition, not to provide therapy itself.
No
The device is described as a syringe for "measure and administer oral medication and enteral nutrition," which are therapeutic and delivery functions, not diagnostic.
No
The device description clearly describes a physical syringe with a barrel, plunger rod, and stopper, indicating it is a hardware device. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "measure and administer oral medication and enteral nutrition." This involves delivering substances into the body, not analyzing samples from the body to diagnose a condition.
- Device Description: The description details a syringe designed for administering liquids orally or enterally. It focuses on the physical mechanism of delivery and safety features related to connection types. There is no mention of analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
Therefore, the BD Oral/Enteral Syringe with BD UniVia Connection is a medical device for administering substances, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The BD Oral/Enteral Syringe with BD UniVia Connection are intended to be used by healthcare professionals to measure and administer oral medication and enteral nutrition.
Product codes
KNT
Device Description
The BD Oral/Enteral Syringe with BD UniVia Connection is a standard piston, syringe which incorporates a safety connector that is incompatible with luer (6%) connectors and intravenous devices. The BD Oral/Enteral Syringe with BD UniVia Connection is designed to mate with a range of enteral feeding extension sets. The 3-piece design syringe consists of a polypropylene barrel and plunger rod and a synthetic rubber stopper. In addition, the plunger rod of the BD Oral/Enteral Syringe with BD UniVia Connection incorporates an orange colorant to further distinguish the device from a standard piston, syringe. The performance of the BD Oral/Enteral Syringe with BD UniVia Connection is equivalent to the predicate device.
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
healthcare professionals
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)
Design Verification tests were performed based on the risk analysis and product requirements, and the results of these tests demonstrate that the BD Oral/Enteral Syringe with BD UniVia connection performed in an equivalent manner to the predicate devices and is safe and effective when used as intended. Design Verification tests for unique BD Oral/Enteral Syringe with BD UniVia Connection performance elements include:
- Tip Cap Leakage: Equivalent performance to predicates
- Connection w/ Mating Devices: Equivalent performance to predicates
- Luer Incompatibility: Equivalent performance to predicates
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K100099, K980987, Class I Exempt
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
0
K 112434
Page 1 of 2
510(K) Summary of Safety and Effectiveness
Date Prepared: 23 August 2011
SEP 2 9 2011
1. Submitted By:
John Roberts Regulatory Affairs Specialist BD Medical - Medical Surgical Systems 1 Becton Drive Franklin Lakes, NJ 07417 201 847 5473 Tel: Fax: 201 847 5307
2. Device Name:
| Trade Name: | BD Oral/Enteral Syringe with BD UniVia Connection |
|---|---|
| Common Name: | Gastrointestinal tubes and accessories |
| Classification Name: | Tube, Feeding |
| Classification: | Class II, 21 CFR 880.5980 |
3. Predicate Device:
| Trade Name: | Children's Medical Ventures Oral/Enteral Syringe |
|---|---|
| Manufacturer: | Children's Medical Ventures |
| 510(k) Number: | K100099 |
| Trade Name: | Becton Dickinson Single Use, Hypodermic Syringe |
| Manufacturer: | Becton, Dickinson and Comoany |
| 510(k): | K980987 |
| Trade Name: | BD Oral Syringe |
| Manufacturer: | Becton, Dickinson and Comoany |
| 510(k): | Class I Exempt |
4. Device Description:
The BD Oral/Enteral Syringe with BD UniVia Connection is a standard piston, syringe which incorporates a safety connector that is incompatible with luer (6%) connectors and intravenous devices. The BD Oral/Enteral Syringe with BD UniVia Connection is designed to mate with a range of enteral feeding extension sets. The 3-piece design syringe consists of a polypropylene barrel and plunger rod and a synthetic rubber stopper. In addition, the plunger rod of the BD Oral/Enteral Syringe with BD UniVia Connection incorporates an orange colorant to further distinguish the device from a standard piston, syringe. The performance of the BD Oral/Enteral Syringe with BD UniVia Connection is equivalent to the predicate device.
1
5. Intended Use:
The BD Oral/Enteral Syringe with BD UniVia Connection are intended to be used by healthcare professionals to measure and administer oral medication and enteral nutrition.
Technological Characteristics: 6.
As compared to the predicate device, the principal device of this 510(k) premarket notification:
- a) Operates under the same operating principle as the predicate device
- b) Has the same barrel, plunger rod and stopper materials as the Becton, Dickinson Single Use Hypodermic Syringe predicate device.
- c) Has the same barrel, plunger rod and stopper design used in the Becton, Dickinson Single Use Hypodermic Syringe predicate device with the exception of the safety connector
- d) Has a similar non-luer connector as the Children's Medical Ventures Oral/Enteral Syringe, with the same design intent
- e) Meets the requirements of ISO 7886-1 and ISO 7886-2 respectively with the exception of the safety connector feature
- Meets the requirements of ISO 10993 as applicable to the intended use of the device f)
- g) Is sterilized to the same sterilization assurance level (SAL) as the predicate device
- h) Demonstrated equivalent performance to the predicate devices during design verification testing.
7. Performance:
Design Verification tests were performed based on the risk analysis and product requirements, and the results of these tests demonstrate that the BD Oral/Enteral Syringe with BD UniVia connection performed in an equivalent manner to the predicate devices and is safe and effective when used as intended. Design Verification tests for unique BD Oral/Enteral Syringe with BD UniVia Connection performance elements include:
| Item# | Performance Specification: | Status of BD Oral/Enteral Syringe: |
|---|---|---|
| 1 | Tip Cap Leakage | Equivalent performance to predicates |
| 2 | Connection w/ Mating Devices | Equivalent performance to predicates |
| 3 | Luer Incompatibility | Equivalent performance to predicates |
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Feed and Drug admini usuanon 10903 New Hampshire Avenue Document Mail Cemer - WO66-G609 Silver Spring, MiD 20995-0002
Mr. John Roberts Regulatory Affairs Specialist BD Medical - Medical Surgical System 1 Becton Drive FRANKLIN LAKES NJ 07417
Q.E.P.D.
Re: K112434
Trade/Device Name: BD Oral/Enteral Syringe with BD UniVia Connection Regulation Number: 21 CFR$ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: August 23, 2011 Received: August 24, 2011
Dear Mr. Roberts:
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.
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 of medical device-related
3
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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.html 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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Herbert Remer MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
112434 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:
BD Oral/Enteral Syringe with BD UniVia Connection
Indications for Use:
The BD Oral/Enteral Syringe with BD UniVia Connection are intended to be used by healthcare professionals to measure and administer oral medication and enteral nutrition.
Over-The-Counter Use Prescription Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Hulas Remon
oductive, Gastro-R
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