(142 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and biological compatibility of the catheters, with no mention of AI or ML.
No.
The device description indicates that these are catheters used for the introduction of washed spermatozoa into the uterine cavity, which is a delivery mechanism, not a therapeutic treatment in itself.
No
The device is used for the introduction of washed spermatozoa into the uterine cavity, which is a therapeutic or procedural function, not a diagnostic one. It facilitates a medical procedure rather than identifying a disease or condition.
No
The device description details physical components like tubing, cannulas, hubs, and positioners, indicating it is a hardware medical device. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the introduction of washed spermatozoa into the uterine cavity." This is a direct therapeutic intervention performed in vivo (within the body), not a test performed in vitro (outside the body) on a sample to diagnose a condition.
- Device Description: The description details a catheter designed for physical insertion into the uterine cavity to deliver a substance. This aligns with a medical device used for a procedure, not a diagnostic test.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze a sample, detect a marker, or provide information for diagnosis. The performance studies focus on the physical properties and biocompatibility of the catheter, as well as its impact on sperm viability after being processed (which is a quality control measure for the sperm preparation, not a diagnostic function of the catheter itself).
- Key Metrics: The key metrics (Human Sperm Survival Assay and Endotoxin) are related to the quality and safety of the device and its interaction with the sperm, not diagnostic performance metrics like sensitivity, specificity, etc.
In summary, the device is a tool for a medical procedure (insemination), not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
Intrauterine Insemination Catheters are used for the introduction of washed spermatozoa into the uterine cavity.
Product codes (comma separated list FDA assigned to the subject device)
MQF
Device Description
Shepard Intrauterine Insemination Set: The Shepard Intrauterine Insemination Set consists of a 5.4 French polyethylene tubing catheter with a connector cap and a stainless steel inner cannula with a female luer lock adapter (FLLA) hub. The assembled device measures 20 cm in length. A silicone positioner is placed 7 cm from the distal tip. The positioner is adjustable to aid in positioning the device to the targeted depth within the uterine cavity during a procedure. The distal end is curved, with a closed ended tip rounded to a smooth finish. One sideport is located just proximal to the distal tip.
Soft-Pass™ Coaxial Insemination Catheter: The Soft-Pass™ Coaxial Insemination Catheter is comprised of a guide catheter and an insemination/transfer catheter. The guide catheter is 6.8 French in diameter and measures 12 cm in length. Ink marks are placed on the distal end of the guide catheter to aid in positioning within the cervical canal. The transfer hub has a female luer adaptor to which the preloaded syringe is affixed. The guide catheter hub and transfer hub connect with a friction fit. The transfer catheter is 4.4 French in diameter.
Insemi-Cath®: The Insemi-Cath® is 3.5 French in diameter and has a length of 13 cm. It is manufactured from nylon tubing that tapers gradually from 0.195 inches at the proximal end that accepts a standard slip tip syringe and tapers for the remaining 7 cm of the catheter. The distal end is manufactured in both curved and straight configurations. The curved Insemi-Cath® features a silicone positioner placed approximately 7 cm from the distal tip. The positioner is adjustable to aid in positioning the device to the targeted depth within the uterine cavity during a procedure. The distal tip of the catheter is rounded to a smooth finish and designed with an open end.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
uterine cavity
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following tests were performed to demonstrate that the minor modifications to the subject IUI catheters have met applicable design and performance requirements to support a determination of substantial equivalence:
- Catheter Aspiration Test: Testing ensures there is no air leaking into the syringe through the catheter. All predetermined acceptance criteria were met.
- Catheter Leak Test: Testing ensures that fluid path catheter assembly does not leak under a predetermined injection pressure. All predetermined acceptance criteria were met.
- Tensile Testing (Catheter Hub- shaft): Testing demonstrated that the tensile strength value was greater than the predetermined acceptance criterion. Acceptance criterion was met.
- Biocompatibility Testing: shows that the subject device sets conform to the biocompatibility requirements of ISO 10993-1:2009. The following tests were performed:
- Cytotoxicity per ISO 10993-5:2009
- Sensitization per ISO 10993-10:2010
- Irritation per ISO 10993-10:2010
- Shelf life: accelerated aging per ASTM F1980-16 to demonstrate that the subject device maintains the mechanical and HSSA specifications after three years of aging.
- Package integrity: per ASTM F1886-09 (visual inspection), ASTM F2096-11 (bubble leak), and ASTM F88-09 (seal strength)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Human Sperm Survival Assay (HSSA), ≥70% motility after 24 hours.
- Endotoxin - (LAL) test per AAMI/ANSI ST72:2011/(R) 2016 and USP .
§ 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).
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December 21, 2017
Cook Incorporated Naomi Funkhouser. MBA Regulatory Affairs Specialist 750 Daniels Way P.O. Box 489 Bloomington, IN 47402
Re: K172321
Trade/Device Name: Shepard, Insemi-Cath®, and Soft-Pass™ Coaxial - Cook Intrauterine Insemination Catheters Regulation Number: 21 CFR& 884.6110 Regulation Name: Assisted Reproduction Catheters Regulatory Class: II Product Code: MQF Dated: November 27, 2017 Received: November 28, 2017
Dear Naomi Funkhouser:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
1
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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Joyce M. Whang -S
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
Shepard, Insemi-Cath®, and Soft-Pass™ Coaxial - Cook Intrauterine Insemination Catheters
Indications for Use (Describe)
Intrauterine Insemination Catheters are used for the introduction of washed spermatozoa into the uterine cavity.
Type of Use (Select one or both, as applicable)
[X] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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COOK INCORPORATED
750 DANIELS WAY, P.O. BOX 489
BLOOMINGTON, IN 47402-0489 U.S.A
PHONE: 812.339.2235 TOLL FREE: 800.457.4500
WWW.COOKMEDICAL.COM
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510(k) Summary - K172321
Shepard. Insemi-Cath®, and Soft-Pass™ Coaxial Cook Intrauterine Insemination Catheters
Date Prepared: December 20, 2017
Submitted By:
Applicant: Contact: Applicant Address:
Contact Phone Number: Contact Fax Number:
Device Information:
Trade Name:
Common Name: Classification Name: Classification Number: Product Code: Device Class: Classification Panel:
Cook Incorporated Naomi Funkhouser. Rohini Patel 750 Daniels Way P.O. Box 489 Bloomington, IN 47402 (812) 339-2235 x104371 (812) 332-0281
Shepard, Insemi-Cath®, and Soft-Pass™ Coaxial -Cook Intrauterine Insemination Catheters Intrauterine Insemination Catheters Assisted Reproduction Catheters 884.6110 MQF - Catheter, Assisted Reproduction Class II Obstetrics/Gynecology
Predicate Devices:
The predicate devices have not been subject to a design-related recall.
Device Description:
Shepard Intrauterine Insemination Set
The Shepard Intrauterine Insemination Set consists of a 5.4 French polyethylene tubing catheter with a connector cap and a stainless steel inner cannula with a female luer lock adapter (FLLA) hub. The assembled device measures 20 cm in length. A silicone positioner is placed 7 cm from the distal tip. The positioner is adjustable to aid in positioning the device to the targeted depth within the uterine cavity during a procedure.
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Page 2 of 4
The distal end is curved, with a closed ended tip rounded to a smooth finish. One sideport is located just proximal to the distal tip.
Soft-Pass™ Coaxial Insemination Catheter
The Soft-Pass™ Coaxial Insemination Catheter is comprised of a guide catheter and an insemination/transfer catheter. The guide catheter is 6.8 French in diameter and measures 12 cm in length. Ink marks are placed on the distal end of the guide catheter to aid in positioning within the cervical canal. The transfer hub has a female luer adaptor to which the preloaded syringe is affixed. The guide catheter hub and transfer hub connect with a friction fit. The transfer catheter is 4.4 French in diameter.
Insemi-Cath®
The Insemi-Cath® is 3.5 French in diameter and has a length of 13 cm. It is manufactured from nylon tubing that tapers gradually from 0.195 inches at the proximal end that accepts a standard slip tip syringe and tapers for the remaining 7 cm of the catheter. The distal end is manufactured in both curved and straight configurations. The curved Insemi-Cath® features a silicone positioner placed approximately 7 cm from the distal tip. The positioner is adjustable to aid in positioning the device to the targeted depth within the uterine cavity during a procedure. The distal tip of the catheter is rounded to a smooth finish and designed with an open end.
Indications for Use:
Intrauterine Insemination Catheters are used for the introduction of washed spermatozoa into the uterine cavity.
Comparison to Predicate Devices:
The subject Shepard IUI set as compared to the predicate device. Shepard IUI Set (K890301), has the same intended use, and is similar in terms of principles of operation, basic technological characteristics, and design. The dimensions of the device are within the range of the predicate, and with a minor design modification to include a winged FLLA. The hub material of the predicate device was not specified, and the subject device hub material is Polycarbonate.
The subject Soft-Pass™ Coaxial Insemination Catheter as compared to the predicate device, Coaxial Catheter Set (K902694), has the same intended use, and is similar in terms of principles of operation, and basic technological characteristics. The Soft-Pass™
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transfer and guide catheter material was changed to Polyethylene and the hub material to HDPE. The hub design was modified to include a friction fit connection, the silicone positioner was removed, and ink marks were placed on the distal end of the guide catheter, rather than the proximal end of transfer catheter. Finally, the guide catheter size and length dimensions were modified to better function with the Soft-Pass™ insemination catheter.
The Insemi-Cath® is identical to the predicate device the Insemi-Cath® II (K902694). The curved version of the subject device has an added silicone positioner.
Special Controls:
The IUI catheters are subject to special controls and must pass HSSA and endotoxin testing. The testing is conducted on a lot-to-lot (batch) basis.
- I Human Sperm Survival Assay (HSSA), ≥70% motility after 24 hours.
- . Endotoxin - (LAL) test per AAMI/ANSI ST72:2011/(R) 2016 and USP .