(21 days)
The 0.9% Sodium Chloride Injection, USP BD Pre-Filled Flush Syringes are intended for use in maintaining patency of vascular access devices (VAD'S).
A comparison between the new 0.9% Sodium Chloride Injection, USP BD Pre-Filled Flush Syringe and the existential BD Preefil Normal Saline Flush Syringe is provided in the table below:
| Component/Characteristic | 0.9% Sodium ChlorideInjection, USP BD Pre-Filled Flush Syringe | BD Preefil NormalSaline Flush Syringe |
|---|---|---|
| Barrel, Plunger Rod, Tip cap | Polypropylene | Polypropylene |
| Lubricant | Medical Grade Silicone | Medical Grade Silicone |
| Plunger Tip (stopper) | Latex Free SyntheticRubber | Latex Free SyntheticRubber |
| Syringe Tip | Luer Lok | Luer Lok |
| Saline Solution | 0.9% Sodium ChlorideInjection, USP | 0.9% Sodium ChlorideInjection, USP |
| Process | Aseptic Fill | Aseptic Fill |
The provided text describes a 510(k) Premarket Notification for a medical device: the "0.9% Sodium Chloride Injection, USP BD Pre-Filled Flush Syringe". This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving that a device meets specific performance acceptance criteria through clinical studies as would typically be described in an AI/ML context.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details cannot be extracted from this document because:
- The document is a 510(k) submission, not a performance study report. It focuses on comparing the new device to a legally marketed predicate device to demonstrate that it is "substantially equivalent" in terms of intended use, technological characteristics, and safety and effectiveness.
- The device is a pre-filled flush syringe, not an AI/ML device. The questions you've asked are highly specific to the evaluation of AI/Machine Learning models, which use algorithms and data to make predictions or classifications. A pre-filled syringe is a physical medical product.
Here's what can be extracted and why the other information is not present:
1. A table of acceptance criteria and the reported device performance:
- Not applicable in the typical sense for a 510(k) submission of this type of device. The "acceptance criteria" here is primarily the demonstration of substantial equivalence to the predicate device, especially regarding design, materials, manufacturing process, and intended use. There are no performance metrics like sensitivity, specificity, accuracy, etc., for a product like a saline flush syringe in this document.
| Component/Characteristic | 0.9% Sodium Chloride Injection, USP BD Pre-Filled Flush Syringe (New Device) | BD Preefil Normal Saline Flush Syringe (Predicate Device) | Equivalence Claim/Performance |
|---|---|---|---|
| Barrel, Plunger Rod, Tip cap | Polypropylene | Polypropylene | Same |
| Lubricant | Medical Grade Silicone | Medical Grade Silicone | Same |
| Plunger Tip (stopper) | Latex Free Synthetic Rubber | Latex Free Synthetic Rubber | Same |
| Syringe Tip | Luer Lok | Luer Lok | Same |
| Saline Solution | 0.9% Sodium Chloride Injection, USP | 0.9% Sodium Chloride Injection, USP | Identical |
| Process | Aseptic Fill | Aseptic Fill | Same |
| Operating principle | Not explicitly detailed, but stated as "Same operating principle" | Not explicitly detailed | Same |
| Operating performance specifications | Not explicitly detailed, but stated as "Same operating performance specifications" | Not explicitly detailed | Same |
| Design | Not explicitly detailed, but stated as "Similar design" | Not explicitly detailed | Similar |
| Product shelf life | Not explicitly detailed, but stated as "Same product shelf life" | Not explicitly detailed | Same |
| Packaging | Not explicitly detailed, but stated as "Same packaging" | Not explicitly detailed | Same |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This document does not describe a "test set" in the context of an AI/ML algorithm evaluation. The comparison is based on materials, design, and manufacturing processes, not empirical data from a clinical trial or performance study with a "test set" of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- No experts used for "ground truth" in this context. The "ground truth" for a device like a syringe is its compliance with specifications, sterility, material properties, and functionality, which are assessed through engineering and quality control tests, not expert human review of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No adjudication method is described because there is no "test set" or diagnostic/interpretive task involved.
5. 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. MRMC studies are for evaluating the performance of diagnostic imaging devices or AI tools that assist human readers. This device is a saline flush syringe.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This pertains to AI algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Different definition of "ground truth". For this device, "ground truth" would be established by physical and chemical testing of the syringe and its contents (e.g., sterility tests, particulate matter tests, chemical analysis of saline, dimensional checks, functional tests for plunger movement and seal integrity, biocompatibility tests for materials). This document does not detail those specific test methods or their results as it is merely a summary for substantial equivalence.
8. The sample size for the training set
- Not applicable. This pertains to AI algorithms.
9. How the ground truth for the training set was established
- Not applicable. This pertains to AI algorithms.
In summary: The provided document is a regulatory submission demonstrating substantial equivalence for a physical medical device (a pre-filled saline flush syringe). It is not a clinical study report for an AI/ML device, hence the absence of information related to AI-specific evaluation criteria.
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human health
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Summary of Safety and Effectiveness for the 0.9% Sodium Chloride Injection, USP BD Pre-Filled Flush Syringe
1 BD Contact person:
Gregory W. Morgan Head of Regulatory Compliance Head of Regulation - Mail Code 226 1 Becton Drive Franklin Lakes, NJ 07417-1880 Phone (201) 847-4344 (201) 847-4855 Fax
- Device Name: 0.9% Sodium Chloride Injection, USP BD Pre-Filled Flush Syringe 2
- Predicate Device(s): 3
- 3.1 BD Preefil™ Normal Saline Flush Syringe K982558
- Intended Uses: 0.9% Sodium Chloride Injection, USP BD Pre-Filled Flush Syringes 4 Intended Uses: 0.9% Sodium Chionde Injection, OSF DB Parcellar access devices (VAD'S).
- Device Description and Comparison: (REVISED) ર
A comparison between the new 0.9% Sodium Chloride Injection, USP BD Pre-Filled
Incomparison Station Childer Flyer Election Elysh Syrings is provided in A comparison between the new 0.5% Boulum Shines injos in the existential in the table below:
| Component/Characteristic | 0.9% Sodium ChlorideInjection, USP BD Pre-Filled Flush Syringe | BD Preefil NormalSaline Flush Syringe |
|---|---|---|
| Barrel, Plunger Rod, Tip cap | Polypropylene | Polypropylene |
| Lubricant | Medical Grade Silicone | Medical Grade Silicone |
| Plunger Tip (stopper) | Latex Free SyntheticRubber | Latex Free SyntheticRubber |
| Syringe Tip | Luer Lok | Luer Lok |
| Saline Solution | 0.9% Sodium ChlorideInjection, USP | 0.9% Sodium ChlorideInjection, USP |
| Process | Aseptic Fill | Aseptic Fill |
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-
Equivalence determination: 6
The 0.9% Sodium Chloride Injection, USP BD Pre-Filled Flush Syringe has the following the The 0.9% Sodium Chionde Injection, OSF - BB Preefil Normal Saline Flush Syringe:
similarities to the predicate BD Preefil Normal Saline Flush Syringe: -
Same syringe components .
-
Syringes have the same operating principle .
-
Syringes have the same operating operformance specifications .
-
Syringes have the similar design .
-
Synngoo nave tion in each product is identical .
-
THE Saline Solution in Sach producing shelf life .
-
The syringes have the same packaging .
In summary, the 0.9% Sodium Chloride Injection, USP BD Pre-Filled Flush Syringer In summary, the 0.9% Sodium Chionde injection, SCF-BB-140-118-11-2
described in this submission is, in our opinion, substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 7 2001
Mr. Gregory W. Morgan Head of Regulatory BD Medical Surgical One Becton Drive MC226 07417 Franklin Lakes, New Jersey
K011982 Re : K011982
Trade/Device Name: 0.9% Sodium Chloride Injection, USP BD Pre-Filled Flush Syringe Regulation Number: 880.5200 Regulatory Class: II Product Code: FOZ June 25, 2001 Dated: June 26, 2001 Received:
Dear Mr. Morgan:
We have reviewed your Section 510(k) notification of intent to We have reviewed your section bronne have determined the market the device referenced above (for the indications for device is substancially ogarransis in marketed predicate use stated in interstate commerce prior to May 28, 1976, devices marketed in theer blace of mevice Amendments, or to the enactment date of the reclassified in accordance with the devices that have been recrassir and Cosmetic Act (Act).
provisions of the Federal Food, Irug, and Cosmetic the general provisions of the reachar room, subject to the general The general controls controls provisions of the Act. controls provisions of the necessor include requirements for annual provisions of the Act incraac requiremanufacturing practice, registration, firsting on a against misbranding and adulteration.
If your device is classified (see above) into either class II If your device is crability (Socialist (Socoval), it may (Special Controls) of Stimal controls. Existing major be subject to such addression be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A rederal Regulations, freic ar, farts on assumes compliance with substantlarly equivatence actor Practice requirements, as set the Current Good Manaractor (QS) for Medical Lorch in the Quarre] Bytoom (2) CFR Part 820) and that, Devices: General regarations, the Food and Drug through periodic go inspections as were in in regulatery Administracion (FBA) will versions in regulation may result in regulatory
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Page 2 – Mr. Morgan
In addition, FDA may publish further announcements action. action. In addition, ron may pagers. Register. Please note: concerning your device in the resimines intension does this response to your premarket hour under sections 531
not affect any obligation you might have under the Electronic not aftect any obligation you might under the Electronic through 542 of the Act for devices under eno 2000-1000
Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as the FDA This letter will allow you co begin maification. The FDA
described in your 510(k) premarket notification a leo described in your 51018) premarke as your device to a legally
finding of substantial equivalence of your device tor your finding of substantial equivatence of yourseification for your
marketed predicate device results in a classification for your marketed predicate device results in a crabbided. The market.
If you desire specific advice for your device on our labeling
If you desire and 201 and additionally 809 10 for in If you desire specific advice for your and additionally 809.10 for in
regulation (21 CFR Part 801 and additionally 809.10 for in regulation (21 CFR Parc 801 una acontact the Office of
yitro diagnostic devices), please contact the for questi vitro diagnostic devices), prease conculture on questions on
Compliance at (301) 594-4622. Additionally, for questions on Compliance at (301) 594-4622. "Addressederice, please contact
the promotion and advertising of your device, please no the promotion and advertising of your acs9300 planes note "Misbranding by reference to the regulation entitled, che regaration" (21CFR 807.97). Other general premarket notification (21ch 007.97). Jost be Act may be information on your responsibilities ands - careers Assistance
obtained from the Division of Small Manufacturers Assistance obtained from the Division of Smarr Manufaceae in
at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address
its Theernet addrebb
"http://www.fda.gov/cdrh/dsma/dsmamajn.html".
Sincerely yours,
Timothy A. Ulatowski Directbr 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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Attachment 2
Indications for Use Statement
510(k) Number: not known at this time
. Device Name: 0.9% Sodium Chloride Injection, USP BD Pre-Filled Flush Syringe
Indications for Use: The 0.9% Sodium Chloride Injection, USP BD Pre-Filled Flush
er and the first for the first and in maintaining patency of vascular access devices Indications for Use: The 0.9% Sodium Chilonde injection, OST 22.4%
Syringes are intended for use in maintaining patency of vascular access devices (VAD'S).
(Division Sign-Off) (Division of Dental, Infection Control, Division of Dental, ----------------------------------------------------------------------------------------------------------------------------------------------------------510(k) Number
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).