(15 days)
Not Found
Not Found
No
The 510(k) summary describes a simple irrigation set and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
The device delivers irrigation solutions, which is a supportive function during medical procedures, not a direct therapeutic action to treat a disease or condition.
No
The device is described as "Irrigation Sets" intended for the "delivery of irrigation solutions" during medical procedures. This function is for direct intervention and delivery, not for diagnosing patient conditions based on data or observations.
No
The device description and intended use clearly describe a physical medical device (irrigation sets) used for delivering fluids, not a software application.
Based on the provided information, the Vital Concepts Irrigation Sets are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the delivery of irrigation solutions to a site within the body (bladder, irrigation site during endoscopic/arthroscopic procedures). This is a direct interaction with the patient's body for therapeutic or procedural purposes.
- IVD Definition: IVDs are devices used to examine specimens from the human body (like blood, urine, tissue) to provide information about a person's health. They are used in vitro (outside the body).
The Vital Concepts Irrigation Sets are used in vivo (within the body) to facilitate a medical procedure. They are a delivery system, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
The Vital Concepts Irrigation Sets are intended for the delivery of irrigation solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic procedures including cystoscopy, transurethral resection (TUR) and arthroscopic procedures.
Product codes
78 LJH, 78 HRX
Device Description
Not Found
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
Physician
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
0
Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three wavy lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Vital Concepts, Inc. c/o N.E. Devine, Jr. Entela, Inc. Engineering and Testing Laboratories 3033 Madison Avenue S.E. GRAND RAPIDS MI 49548
Re: K032832
Trade/Device Name: Irrigation Sets Regulation Number: None Regulatory Class: Unclassified Product Code: 78 LJH Regulation Number: 21 CFR §888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: 78 HRX Dated: September 11, 2003 Received: September 11, 2003
Dear Mr. Devine:
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.
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); 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.
SEP 2 6 2003
1
This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. Ixxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmadsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number:
032832
Device Name: Irrigation Sets
Classification Panel: Unclassified 78 LJH 21 CFR 888.1100 87 HRX
Indications for Use:
The Vital Concepts Irrigation Sets are intended for the delivery of irrigation solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic procedures including cystoscopy, transurethral resection (TUR) and arthroscopic procedures.
Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a Physician.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use:
Over-the-Counter Use:
David A. Szyomm
(Division Sign-Off)
Division of Reproductive, Abd and Radiological Devic 510(k) Number