(66 days)
The sterile singe-use catheter is intended for introducing washed spermatozoa into the uterine cavity.
The Intrauterine Insemination Catheter is a singe-use, sterile, disposable device for use in intrauterine insemination. The catheter has two opposing smooth side eyes and a rounded, smooth, closed distal tip. The device has an overall length of 18cm and consists of a flexible end inner catheter and a detachable outer sheath, which is attached to the inner catheter by a Luer lock. The inner catheter is 16 gauge with a uniform lumen throughout its length. When the outer sheath Luer is attached to the catheter, the inner catheter protrades from the outer sheath by 5cm. The outer sheath has a series of 1cm graduations at the distal end. The device is identified as AR-IUI.
This 510(k) summary describes a medical device, the CooperSurgical Intrauterine Insemination Catheter, and its substantial equivalence to a predicate device. It does not contain the kind of performance data that would typically be described with acceptance criteria and a study proving a device meets those criteria in the context of an AI/algorithm-based medical device.
The information provided focuses on material composition, intended use, and general safety/effectiveness of a physical medical device compared to an existing one. There is no mention of an algorithm, AI, or any performance metrics like sensitivity, specificity, or accuracy that would be associated with such a system.
Therefore, I cannot provide the requested table and study details. The document explicitly states:
- "The subject device has been subject to biocompatibility testing (for the materials that is equivalent to ISO 10993-1 Biocompatibility requirements. The subject device also complies with ISO 594-1 1986 Conical fittings with a 6% (luer) taper requirements." This indicates testing related to material safety and mechanical fit, not an algorithm's performance.
- "CooperSurgical, Inc. believes that the subject device is substantially equivalent to the predicate device. The subject device is composed of the same materials, sterilized using the same method, complies with the same standards, has the same indications for use, and has the same working dimensions." This is the core argument for its approval, not a performance study as you've described.
In summary, this document is for a physical medical device (catheter), not an AI/algorithm-based diagnostic or assistive device that would have the type of performance criteria and studies you are asking about.
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510 (k) Summary
DEC 1 3 2002
Date Prepared [21 CFR 807.92(a)(1)|
October 7, 2002
Submitter's Information [21 CFR 807.92(a)(1)]
Joseph M. Azary C/o CooperSurgical, Inc. P.O. Box 2156 Huntington, CT. 06484
Azary Technologies has received authorization to submit this 510(k) on behalf of the sponsor CooperSurgical, Inc., 95 Corporate Drive, Trumbull, CT 06611. CooperSurgical, Inc. is an FDA-registered medical device under establishment# 1216677.
Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
The device trade names are: CooperSurgical Intrauterine Insemination Catheter Common Name: Assisted Reproduction Catheter, Intrauterine Insemination Cannula
Predicate Device [21 CFR 807.92(a)(3)|
Wallace Artificial Insemination Catheters - K964848
The subject devices have the same indications for use, material composition, sterilization method, and working dimensions as the predicate device. A minor difference lies in the fact that the luers of the subject device are slightly larger (both in diameter and length) than the predicate device. The subject device is packaged in a pouch composed of Tyvek and film, whereas the predicate device is packaged in a pouch composed of paper and film.
Description of the Device [21 CFR 807.92(a)(4)}
The Intrauterine Insemination Catheter is a singe-use, sterile, disposable device for use in intrauterine insemination. The catheter has two opposing smooth side eyes and a rounded, smooth, closed distal tip. The device has an overall length of 18cm and consists of a flexible end inner catheter and a detachable outer sheath, which is attached to the inner catheter by a Luer lock. The inner catheter is 16 gauge with a uniform lumen throughout its length. When the outer sheath Luer is attached to the catheter, the inner catheter protrades from the outer sheath by 5cm. The outer sheath has a series of 1cm graduations at the distal end. The device is identified as AR-IUI.
The subject devices will be packaged in a flexible pouch composed of Tyvek heat sealed to polyethylene film. The pouch is designed to be peeled open. The pouch will be placed in a white SBS carton will contain 25 / 50 units. The subject devices will be sterilized using a validated Ethylene Oxide cycle affording an SAL of 104.
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| Component | Material | Details |
|---|---|---|
| Inner Catheter | Polyurethane | Pellethane 2363-90A R0120 Poly-urethane |
| Outer Sheath | Teflon | Fluortek FEP-20 White (akaNeoflon NP-20) with 8-10% Bar-ium Sulfate. |
| Luers | Polypropylene (with Pink andRed Colorants). | Montellprofax 6323 Compoundedby Chroma with PMS 240 U Pink.PMS Red #512035 in HDPE Col-orant. |
| Tip Protector | Polyethylene | No patient contact |
The subject devices are composed of the following materials:
Intended Use [21 CFR 807.92(a)(5)]
The sterile singe-use catheter is intended for introducing washed spermatozoa into the uterine cavity.
Technological Characteristics [21 CFR 807.92(a)(6)]
CooperSurgical, Inc. believes that the subject device is substantially equivalent to the predicate device. The subject device is composed of the same materials, sterilized using the same method, complies with the same standards, has the same indications for use, and has the same working dimensions. The minor differences are with the packaging and the outer diameter and length of the Luer.
Performance Data [21 CFR 807.92(b)(1)]
The subject device has been subject to biocompatibility testing (for the materials that is equivalent to ISO 10993-1 Biocompatibility requirements. The subject device also complies with ISO 594-1 1986 Conical fittings with a 6% (luer) taper requirements.
Conclusion [21 CFR 807.92(b)(3)]
We believe the changes are minor and conclude that the subject devices are as safe and effective as the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a simple, sans-serif font and is left-aligned. The text is black against a white background, making it easily readable.
ood and Drug Administratio 00 Cornorate Boulevard ockville MD 20850
CooperSurgical, Inc. % Mr. Joseph M. Azary Azary Technologies, LLC P.O. Box 2156 HUNTINGTON CT 06484 Re: K023383 Trade/Device Name: CooperSurgical Intrauterine Insemination Catheter Regulation Number: 21 CFR 884.6110 Regulation Name: Assisted reproduction catheters Regulatory Class: II Product Code: 85 MOF Dated: October 7, 2002 Received: October 8, 2002
Dear Mr. Azary:
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 (OS) 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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Page 2
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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FDA 510(k) Premarket Notification CooperSurgical Intrauterine Insemination Catheter
5 10(k) Number (if known):
Device Name: CooperSurgical, Inc. - Intrauterine Insemination Catheter
Indications For Use: The sterile singe-use catheter is intended for introducing washed spermatozoa into the uterine cavity. . .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96
Ermil A. Slegm
(Division Sion-Off) Division of Reproductiv e. Abdominal. and Radiological De 510(k) Numbe
Page 4 510(k) Intrauterine Insemination Catheter
§ 884.6110 Assisted reproduction catheters.
(a)
Identification. Assisted reproduction catheters are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to introduce or remove gametes, zygote(s), preembryo(s), and/or embryo(s) into or from the body. This generic type of device may include catheters, cannulae, introducers, dilators, sheaths, stylets, and component parts.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).