(41 days)
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.
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.
The provided text describes a 510(k) submission for a medical device called "TheCurve™," an intrauterine insemination catheter. The submission aims to demonstrate substantial equivalence to a predicate device, the "Select IUI®."
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The documents do not explicitly state "acceptance criteria" in a quantitative sense as might be found in a performance study with defined thresholds (e.g., minimum sensitivity, specificity). Instead, the submission focuses on demonstrating substantial equivalence to a predicate device based on design, materials, function, and intended use. The "performance" is implicitly deemed acceptable if the device is found substantially equivalent to the already approved predicate.
| Feature | TheCurve™ (New Device) Performance | Select IUI® (Predicate Device) Performance | Equivalence Justification |
|---|---|---|---|
| Intended Use | Single use, sterile, disposable, flexible catheter designed for intrauterine artificial insemination. | Single use, sterile, disposable, flexible catheter designed for intrauterine artificial insemination. | Identical |
| Constituent Materials | Identical to Select IUI®. | Identical to TheCurve™. | Identical |
| Length (Effective) | 17.2 cm | 17 cm | Minor difference (1 mm shorter), not cited as a concern for effectiveness or safety. |
| Length (Overall) | 19.9 cm | 20 cm | Minor difference (1 mm shorter), not cited as a concern for effectiveness or safety. |
| ID (Inner Diameter) | 1.1 mm for effective length | 1.6 mm for effective length | Minor difference (0.5 mm smaller). The implication on performance (e.g., flow rate) is not discussed in detail but is implicitly deemed acceptable given the substantial equivalence claim. |
| 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 | Differences in distal OD are minor and related to the curvature of TheCurve™. Implicitly deemed acceptable. |
| Graduation Marks | Identical to Select IUI® (six colored markings at 5, 6, 7, 8, 9, and 10 cm from the distal tip). | Identical to TheCurve™. | Identical |
| Design | Inner polyethylene tube within an outer polypropylene sheath. Distal portion is curved. Extreme distal tip is open. | Inner polyethylene tube within an outer polypropylene sheath. Distal portion is straight. Extreme distal tip is closed with two side openings. | Differences (curved distal tip, open vs. closed distal tip) are described as improvements to ease insertion. Implicitly deemed acceptable for maintaining or improving safety and effectiveness. |
| Function | Identical to Select IUI® (channel for flow). | Identical to TheCurve™. | Identical |
2. Sample Size Used for the Test Set and Data Provenance
The documents do not describe a formal "test set" or a study with human subjects (clinical trial) to evaluate the device's performance against specific acceptance criteria. This submission is a 510(k) for substantial equivalence based on device comparison and technical specifications, not a clinical performance study. Therefore, there's no sample size or data provenance in the context of a clinical test set.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. As no clinical study or performance evaluation with a "ground truth" was conducted or reported, no experts were involved in establishing such ground truth for a test set. The "truth" in this submission relies on the comparison of engineering specifications and intended use to a predicate device.
4. Adjudication Method for the Test Set
Not applicable. No test set requiring adjudication was used.
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. This device is a manual medical instrument (an intrauterine insemination catheter), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI performance is irrelevant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a manual medical instrument and does not involve an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the conventional sense of a clinical study. The "ground truth" for this 510(k) submission is the pre-existing regulatory approval and established safety and effectiveness of the predicate device (Select IUI®). The new device, TheCurve™, is compared against the predicate's specifications and intended use.
8. The Sample Size for the Training Set
Not applicable. Since there's no algorithm involved, there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. Since there's no algorithm involved, there is no "training set" or ground truth for it.
In summary:
This 510(k) submission relies on a "benchmarking" or "comparison" approach rather than a clinical performance study with a defined test set and acceptance criteria. The "acceptance criteria" are implicitly met if the FDA determines the new device is substantially equivalent to the predicate device in terms of safety and effectiveness, despite some minor physical differences that are argued to either have no impact or slightly improve usability (e.g., curved tip for easier insertion). The evidence provided is primarily a detailed technical comparison of the new device with the legally marketed predicate device.
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OCT 1 1 2001
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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.
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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 to1.6 mm for distal 4.5 cm oflength | 2.6 mm stepped down to2.1 mm for distal 4.5 cm oflength |
| Graduation marks | Identical for both devices | |
| Design | Identical for both devices. The distal portion, however ofTheCurve is curved while the distal portion of the Select IUIis 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.
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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.
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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
12
§ 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).