(41 days)
Not Found
No
The description focuses on the physical design and materials of a catheter for intrauterine insemination, with no mention of AI or ML capabilities.
No.
The device is a catheter for artificial insemination, which is a diagnostic or procedural tool, not a device that directly treats a disease or condition for therapeutic purposes.
No
The device description indicates it is a catheter designed for intrauterine artificial insemination, which is a therapeutic procedure involving the introduction of substances into the body, rather than identifying a medical condition.
No
The device description clearly details a physical catheter made of polyethylene and polypropylene, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "intrauterine artificial insemination." This is a procedure performed on a patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a catheter designed for insertion into the uterus to deliver something (presumably sperm). This is a medical device used for a therapeutic or procedural purpose, not for diagnosing a condition based on in vitro analysis.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or using reagents to detect specific substances. The device is purely mechanical for delivery.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
As the Select IUI® (predicate device), TheCurve™ (new device) is a single use, sterile, disposable, flexible catheter designed to be used for intrauterine artificial insemination.
Product codes
85 MFD
Device Description
TheCurve, such as the Select IUI, comprises a long clear polyethylene tube that is tightly surrounded on three quarters of its proximal length by an outer, clear polypropylene sheath. This leaves 4.5 cm of the inner polyethylene tube exposed at the distal end of the device. The proximal inner tube and outer sheath circumferences are molded directly onto the distal end of a luer lock hub so that only the lumen of the inner tube can provide a channel for flow. This design results in a single-channel catheter with two segments each having different degrees of flexibility.
The extreme distal tip of TheCurve™ is open as compared to the extreme distal tip of the Select IUI® which is closed and has two side openings.
Both TheCurve and Select IUI have six (6) coloured graduation markings placed at 5, 6, 7, 8, 9, and 10 cm distance from the extreme distal tip of the catheter.
The distal portion of TheCurve is curved while the distal portion of the Select IUI is straight.
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
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Select IUl@
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.5250 Cervical cap.
(a)
Identification. A cervical cap is a flexible cuplike receptacle that fits over the cervix to collect menstrual flow or to aid artificial insemination. This generic type of device is not for contraceptive use.(b)
Classification. Class II (performance standards).
0
OCT 1 1 2001
Image /page/0/Picture/1 description: The image shows a black square with a white, curved shape inside. The white shape starts at the bottom left corner of the square and curves upwards towards the top center. The shape is narrow and elongated, resembling a stylized flame or a curved line. The background is solid black, providing a stark contrast to the white shape.
SELECT MEDICAL SYSTEMS INC.
K012935
page 1 of 2
Section M Page 1 of 2
Food and Drug Administration Center for Devices and Radiological Health (HFZ-401) 9200 Corporate Boulevard Rockville MD 20850
510(k) Summary
Select Medical Systems, Inc Submitter 30 Winter Sport Lane Williston VT 05495
Ph (802) 862-1017
(802) 862-3767
Fx
Contact person
Date of Summary
MM DD YY
Monique Girard
TheCurve™ Device prorietary name
Device common/usual name Intrauterine insemination catheter
Intrauterine insemination cannula Device classification name
Select IUl@ Predicate device name
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92(c).
Intended use
As the Select IUI® (predicate device), TheCurve™ (new device) is a single use, sterile, disposable, flexible catheter designed to be used for intrauterine artificial insemination.
Description of new device and comparison with predicate device.
TheCurve, such as the Select IUI, comprises a long clear polyethylene tube that is tightly surrounded on three quarters of its proximal length by an outer, clear polypropylene sheath. This leaves 4.5 cm of the inner polyethylene tube exposed at the distal end of the device. The proximal inner tube and outer sheath circumferences are molded directly onto the distal end of a luer lock hub so that only the lumen of the inner tube can provide a channel for flow. This design results in a single-channel catheter with two segments each having different degrees of flexibility.
1
Image /page/1/Picture/0 description: The image shows a black square with a white, curved shape inside. The shape resembles a stylized wave or a crescent moon. The white shape starts at the bottom left corner and curves upwards towards the top right, creating a dynamic and flowing composition against the dark background.
K012935
Page 2 of 2
Section M Page 2 of 2
The extreme distal tip of TheCurve™ is open as compared to the extreme distal tip of the Select IUI® which is closed and has two side openings.
Both TheCurve and Select IUI have six (6) coloured graduation markings placed at 5, 6, 7, 8, 9, and 10 cm distance from the extreme distal tip of the catheter.
The distal portion of TheCurve is curved while the distal portion of the Select IUI is straight.
Product specifications - Summary
| TheCurve (new device) | Select IUI (predicate device) | |
|---|---|---|
| Length | 17.2 cm (effective) | |
| 19.9 cm (overall) | 17 cm (effective) | |
| 20 cm (overall) | ||
| ID (inner diameter) | 1.1 mm for effective length | 1.6 mm for effective length |
| OD (outer diameter) | 2.6 mm stepped down to | |
| 1.6 mm for distal 4.5 cm of | ||
| length | 2.6 mm stepped down to | |
| 2.1 mm for distal 4.5 cm of | ||
| length | ||
| Graduation marks | Identical for both devices | |
| Design | Identical for both devices. The distal portion, however of | |
| TheCurve is curved while the distal portion of the Select IUI | ||
| is straight. | ||
| Function | Identical for both devices | |
| Materials | Identical for both devices | |
| Intended use | Identical for both devices |
Substantial equivalence
TheCurve is substantially equivalent in safety and effectiveness to the Select IUI as both devices are identical in terms of raw materials, intended use, function, graduation markings and they have a similar design. There are three minor differences: (i) TheCurve is 1 mm shorter than the Select IUI: (ii) TheCurve has an ID of 0.5 mm smaller than the Select IUI; (iii) and, the distal portion of TheCurve is slightly curved to ease its insertion into the cervical os and through the cervical canal.
2
Image /page/2/Picture/1 description: The image shows a logo for the U.S. Department of Health. The logo features a stylized abstract design of three curved lines that resemble a bird in flight. To the left of the bird is the text "DEPARTMENT OF HEALTH" written vertically.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 1 2001
Ms. Monique Girard Regulatory Affairs Manager Select Medical Systems, Inc. 30 Winter Sport Lane P.O. Box 966 WILLISTON VT 05495-0966 Re: K012935
Trade/Device Name: TheCurve™ Item 507 Intrauterine Insemination Cannula Regulation Number: 21 CFR 884.5250 Regulation Name: Cervical Cap Regulatory Class: II Product Code: 85 MFD Dated: August 29, 2001 Received: August 31, 2001
Dear Ms. Girard:
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.
3
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 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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SECTION C – PAGE 1 OF 1
STATEMENT OF INDICATIONS FOR USE
510(k) number (if known)
Device name
Miles (14) 1940 1940 1940) 1978-1999
TheCurve™
Indication(s) for use
Intrauterine artificial insemination
Nancy C Brogdon
Division of Reproductive, Abdominal
and Radiological Devices
510(k) Number K012925
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