(128 days)
The sterile water and sterile saline are indicated for device irrigation only.
The Welcon Sterile Water for Irrigation and Sterile 0.9% Normal Saline for irrigation are indicated for use in device irrigation procedures. The sterile water and saline are not indicated for injection.
The Welcon Sterile Water and Sterile 0.9% Normal Saline for Device Irrigation are individual, single-use 4 oz. (120 ml.) cups of fluid intended to be used for irrigation. The individual container consists of a plastic cup with a heat-sealed, adhesive-backed foil lid.
The provided text is for a 510(k) premarket notification for "Sterile Water/Saline for Device Irrigation." This product is a medical device, but it is not an AI/ML powered device.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information is not applicable to this document.
The document explicitly states: "Substantial equivalence for these devices was based solely on design characteristics; no performance or safety data was included in this premarket notification. The materials, performance specifications and essential design characteristics of the Welcon devices are identical to those of the Intermed predicate devices."
The only "testing" mentioned is: "USP bacterial endotoxin testing was performed to verify that the sterile water and saline solutions conform with USP requirements." This is a quality control test to ensure the product meets a basic sterility standard, not a performance study as would be conducted for an AI/ML device.
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Sterile Water/Saline for
510(k) Summary
Pursuant to 512(i)(3)(A) of the Food, Drug and Cosmetic Act, Welcon, Inc. is required to submit with this Premarket Notification either an "... adequate summary of any information respecting safety and effectiveness or state that information will be made available upon request of any person." Welcon chooses to submit a summary of the safety and cffectiveness information. The summary is as follows:
| Trade Name: | Welcon Sterile Water for Device IrrigationWelcon Sterile 0.9% Normal Saline for Device Irrigation |
|---|---|
| Owner/Operator: | Welcon, Inc.99 Hartford AvenueProvidence, RI 02909 |
| Distributed by: | Welcon, Inc.303 Main Street, Suite 300Fort Worth, TX 76102 |
| Manufacturing Site: | Intermed, Inc.15 White Lake RoadSparta, NJ 07871 |
| Device Generic Name: | Sterile water/sterile saline for device irrigation |
| Classification: | According to Section 513 of the Federal Food, Drug, andCosmetic Act, the device classification is Class II, Performance Standard(79LWD). |
| Predicate Devices: | Sterile Water for Irrigation (Catalog #5575)Intermed, Inc.Sparta, New Jersey 07871K842166Sterile 0.9% Saline for Irrigation (Catalog #5565)Intermed, Inc.Sparta, New Jersey 07871K842166 |
Product Description:
The Welcon Sterile Water and Sterile 0.9% Normal Saline for Device Irrigation are individual, single-use 4 oz. (120 ml.) cups of fluid intended to be used for irrigation. The individual container consists of a plastic cup with a heat-sealed, adhesive-backed foil lid.
Indications for Use:
The sterile water and sterile saline are indicated for device irrigation only.
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Safety and Performance:
Substantial equivalence for these devices was based solely on design characteristics; no performance or safety data was included in this premarket notification. The materials, performance specifications and essential design characteristics of the Welcon devices are identical to those of the Intermed predicate devices. USP bacterial endotoxin testing was performed to verify that the sterile water and saline solutions conform with USP requirements.
Conclusion:
Based on the indications for use, tochnological characteristics, and comparison to predicate devices, the Welcon Sterile Water and Sterile 0.9% Normal Saline for Device Irrigation have been shown to be safe and effective for its intended use.
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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 stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 5 1998
Ms. Pamela Papineau C/O Delphi Medical Device Consulting Welcon, Incorporated 99 Hartford Avenue 02909 Providence, Rhode Island
K973734 Re : Sterile Water for Device Irrigation/Sterile Trade Name: 0.9% Saline for Device Irrigation Requlatory Class: II Product Code: JOL Dated: January 16, 1998 January 20, 1998 Received:
Dear Ms. Papineau:
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 requlations 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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does
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Page 2 - Ms. Papineau
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 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 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) 594-4618. 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.fdf.gov/cdrh/dsmamain.html".
Sincerely yours
Timothy A. Ulatowski
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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of Page 1 _
510(k) Number (if known):
Sterile Water for Irrigation/Sterile 0.9% Normal Saline for Device Name: Device Irrigation
Indications for Use:
The Welcon Sterile Water for Irrigation and Sterile 0.9% Normal Saline for irrigation are indicated for use in device irrigation procedures. The sterile water and saline are not indicated for injection.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER - - - -PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aner Nariani for PLC
(Division Sie Division of Den and Gene sral He 510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-the -Counter Use ________________________________________________________________________________________________________________________________________________________
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§ 880.6740 Vacuum-powered body fluid suction apparatus.
(a)
Identification. A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.