(207 days)
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No
The summary describes a fluid management system for hysteroscopy and does not mention any AI or ML capabilities.
Yes
The device is used to distend the uterus for hysteroscopy and monitors intrauterine pressure, fluid use, and fluid deficit, which are direct interventions for medical purposes.
No
The device is used for fluid management and monitoring during hysteroscopy, which is a therapeutic or interventional procedure, not primarily for diagnosis.
No
The device description clearly states it is a "Fluid Management System" which implies hardware components for fluid delivery, pressure monitoring, and measurement, not just software.
Based on the provided information, the DOLPHIN® II Fluid Management System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a system that provides fluid distension and monitors parameters within the body (uterus) during a medical procedure (hysteroscopy). This is a therapeutic or procedural device, not a device used to examine specimens outside the body to diagnose or monitor a condition.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing diagnostic information based on laboratory analysis
The DOLPHIN® II Fluid Management System is clearly designed for use during a medical procedure to manage fluid and pressure within the uterus. This falls under the category of a surgical or procedural device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The DOLPHIN® II Fluid Management System provides low viscosity liquid distension of the uterus for hysteroscopy, and monitors intrauterine pressure, fluid use and fluid deficit.
Product codes
85 HIG
Device Description
The DOLPHIN® II Fluid Management System provides low viscosity liquid distension of the uterus for hysteroscopy, and monitors intrauterine pressure, fluid use and fluid deficit.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
uterus
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 884.1700 Hysteroscopic insufflator.
(a)
Identification. A hysteroscopic insufflator is a device designed to distend the uterus by filling the uterine cavity with a liquid or gas to facilitate viewing with a hysteroscope.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter fits which only include accessory instruments that are not used to effect intrauterine access, e.g., hysteroscopic introducer sheaths, etc.; and single-use tubing kits used for only intrauterine insufflation. 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 § 884.9.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
8 2002 JAN
Mr. John A. Delucia Vice President, Regulatory Affairs, Quality Assurance and Clinical Affairs CIRCON CORPORATION 492 Old Connecticut Path FRAMINGHAM MA 01701-4584
Re: K011876
Trade/Device Name: DOLPHIN® II Fluid Management System Regulation Number: 21 CFR 884.1700 Regulation Name: Hysteroscopic insufflator Regulatory Class: II Product Code: 85 HIG Dated: October 11, 2001 Received: October 12, 2001
Dear Mr. Delucia:
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 10 was barned in the Mer. 28, 1976, the enactment date of the Medical Device Amendments, or to conniner of the 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 I ou may, atores, orovisions 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 comply with and the Fee broquiers 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.
1
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 nredicate 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 this letter:
| 8xx.1xxx | (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" (21 CFR Part 807.97). 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/dsma/dsmamain.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
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CIRCON CORPORATION CONFIDENTIAL
CIRCON CORPORATION
DOLPHIN® II Fluid Management System FDA Premarket Notification 510(k)
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K 011876
Device Name: DOLPHIN® II Fluid Management System
The DOLPHIN® II Fluid Management System provides low viscosity liquid distension of the uterus for hysteroscopy, and monitors intrauterine pressure, fluid use and fluid deficit.
(PLEASE NO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CRDH, Office of Device Evaluation (ODE)
Dinard G. Symon
Prescription Use