(233 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and basic functional performance of a catheter, with no mention of AI or ML capabilities.
Yes
The device aids in the introduction of washed spermatozoa, which is a therapeutic intervention for infertility.
No
The device is primarily used for the introduction of spermatozoa or saline for sonohysterography, which are procedural and diagnostic aids, but the device itself does not perform diagnosis.
No
The device description clearly states it is a physical catheter made of polyethylene with a silicone positioner, indicating it is a hardware medical device.
Based on the provided information, the Soules Intrauterine Insemination Catheter is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to access the uterine cavity for saline infusion sonohysterography or for the introduction of washed spermatozoa. This is a medical device used for a procedure within the body, not for testing samples in vitro (outside the body).
- Device Description: The description details a physical catheter designed for insertion into the uterine cavity.
- Performance Studies: The performance studies focus on the physical and biological compatibility of the device itself (sterilization, integrity, sperm survival in contact with the device, endotoxin levels, dimensions, etc.), not on the diagnostic analysis of biological samples.
- Key Metrics: The key metrics relate to the device's performance and safety in its intended use (sperm motility after contact with the device, endotoxin levels), not diagnostic accuracy metrics like sensitivity or specificity.
IVDs are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device is used to deliver substances into the body or facilitate imaging within the body.
N/A
Intended Use / Indications for Use
The Soules Intrauterine Insemination Catheter is used to access the uterine cavity for saline infusion sonohysterography or for the introduction of washed spermatozoa into the uterine cavity.
Product codes (comma separated list FDA assigned to the subject device)
MOF, LKF
Device Description
The Soules Intrauterine Insemination Catheter consists of a 5.3 French polyethylene catheter that is 25 cm in length with a polyethylene female luer adapter hub. The tip of the device features an oval side port located ~2.5 mm from the distal end of the catheter. A 3 mm movable silicone positioner is also present on the shaft of the catheter that can be adjusted to aid in positioning the device to the targeted depth within the uterine cavity during a procedure.
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 proposed Soules Intrauterine Insemination Catheter met the applicable design and performance requirements and support a determination of substantial equivalence under the specified testing parameters. These tests include:
- Sterilization Validation per ISO 11135-1:2007 and ISO 10993-7: 2008.
- Package integrity testing following real-time aging:
- Bubble leak test per ASTM F2096-04 .
- Seal strength testing per ASTM F88-09
- Visual Inspection per ASTM F1886-09
- Human Sperm Survival Assay - Testing ensures manufacturing materials do not have an adverse effect upon the survival of Human Sperm. Test articles assessed provided acceptable results of ≥ 70% motility at 24 hours.
- Endotoxin Assay (AAMI ST72: 2011 and UPS/NF )
§ 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 14, 2017
Cook Incorporated Naomi N. Funkhouser Regulatory Affairs Specialist 750 Daniels Way Bloomington. Indiana 47404
Re: K163318
Trade/Device Name: Soules Intrauterine Insemination Catheter Regulation Number: 21 CFR 884.6110 Regulation Name: Assisted Reproduction Catheters Regulatory Class: Class II Product Code: MOF, LKF Dated: June 13, 2017 Received: June 13, 2017
Dear Naomi N. 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. 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
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
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
2
Indications for Use
510(k) Number (if known) K163318
Device Name
Soules Intrauterine Insemination Catheter
Indications for Use (Describe)
The Soules Intrauterine Insemination Catheter is used to access the infusion sonohysterography or for the introduction of washed spermatozoa into the uterine cavity.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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750 DANIELS WAY, P.O. P.O. P
K163318 Page 1 of 4
510(k) SUMMARY- K163318
Date Prepared: July 11, 2017
Submitted By:
| Applicant: | Cook Incorporated |
|---|---|
| Contact: | Naomi N. Funkhouser |
| Applicant Address: | Cook Incorporated |
| 750 Daniels Way | |
| Bloomington, IN 47404 | |
| Contact Phone Number: | (812) 335-3575 x10-4371 |
| Contact Fax Number: | (812) 332-0281 |
Device Information:
Trade Name: Common Name: Classification Name: Regulation Number: Product Code:
Product Class:
Soules Intrauterine Insemination Catheter Intrauterine insemination catheter Assisted Reproduction Catheters 21 CFR §884.6110 MQF (Catheter, Assisted Reproduction) LKF (Cannula, Manipulator/Injector, Uterine) II
Predicate Device:
K061679 – Wallace SIS/AI Catheter (Irvine Scientific Sales Co., Inc.). This device has not been subject to a design-related recall.
Device Description:
The Soules Intrauterine Insemination Catheter consists of a 5.3 French polyethylene catheter that is 25 cm in length with a polyethylene female luer adapter hub. The tip of the device features an oval side port located ~2.5 mm from the distal end of the catheter. A 3 mm movable silicone positioner is also present on the shaft of the catheter that can be adjusted to aid in positioning the device to the targeted depth within the uterine cavity during a procedure.
4
Indication for Use:
The Soules Intrauterine Insemination Catheter is used to access the uterine cavity for saline infusion sonohysterography or for the introduction of washed spermatozoa into the uterine cavity.
| K163318- Subject Device | K061679 - Predicate Device | |
|---|---|---|
| Intended Use | ||
| Indication for Use | The Soules Intrauterine Insemination | |
| Catheter is used to access the uterine | ||
| cavity for saline infusion | ||
| sonohysterography or for the | ||
| introduction of washed spermatozoa | ||
| into the uterine cavity. | The wallace SIS/AI catheter is | |
| intended to be used in artifical | ||
| insemination procedures intended for | ||
| insertion of the catheter and | ||
| introduction of washed spermatozoa | ||
| into the uterine cavity. The wallace | ||
| sis/ai catheter is also intended to be | ||
| used in saline infusion sonography | ||
| (SIS) also known as saline infusion | ||
| sonohysterography (SIS) and saline | ||
| ultrasound infusion procedures in the | ||
| detection abnormalities within uterine | ||
| cavities. | ||
| Technology | ||
| Tubing | Polyethylene | FEP, polyurethane, LDPE, and Nylon |
| Hub | Polyethylene | Polypropylene and Nylon |
| Tubing Length, | ||
| Width | 25 cm, 5.3 Fr | 18 cm, 16 Gauge (5.0 Fr) – inner |
| catheter. | ||
| Device Design | Single lumen catheter with a luer lock | Inner catheter and a detachable outer |
| sheath that attaches to the inner | ||
| catheter by a luer lock | ||
| When the outer sheath is attached to | ||
| the hub of the catheter, the inner | ||
| catheter protrudes from the distal end | ||
| of the outer sheath by 5 cm | ||
| Side port | Single oval side port 2-3 mm from | |
| distal tip | Dual oval Side ports on distal tip | |
| Depth indicator | One adjustable 3 mm silicone band | |
| initially placed 7 cm from distal tip of | ||
| catheter | Five - 1 cm graduations ink marks on | |
| outer catheter | ||
| Sterilization | EtO | EtO |
5
The subject and predicate device have the same intended use - the delivery of washed spermatozoa to the uterine cavity and SIS. In addition, the subject and predicate devices are similar in some technological features, including design (e.g., tip and hub design), usability, hub adapter, and sterility procedure.
However, there are a number of differences between the subject and predicate device that are described below:
- . Device materials - Some of the device materials (e.g., tubing, hub, depth indicator) are not the same. Materials differences are common in ART devices and do not raise different questions of safety and effectiveness, and can be addressed through testing (e.g., biocompatibility, performance).
- Device dimensions - The subject device has differences in device dimensions (e.g., greater length). These differences do not raise different questions of safety or effectiveness.
- Device Design- The subject device has an adjustable silicone depth indicator ● whereas the predicate device has five graduation ink marks on the catheter. In addition, the subject device has a single side port whereas the predicate device a double side port. The subject device is a single catheter whereas the predicate device has an inner catheter with a detachable outer sheath that attaches to the inner catheter. The differences between the device designs do not raise different questions of safety and effectiveness (e.g., ability to access the uterine cavity, risk of perforation, etc.).
Performance Testing:
The following tests were performed to demonstrate that the proposed Soules Intrauterine Insemination Catheter met the applicable design and performance requirements and support a determination of substantial equivalence under the specified testing parameters. These tests include:
- Sterilization Validation per ISO 11135-1:2007 and ISO 10993-7: 2008. 1.
-
- Package integrity testing following real-time aging:
- Bubble leak test per ASTM F2096-04 .
- . Seal strength testing per ASTM F88-09
- Visual Inspection per ASTM F1886-09 ●
6
-
- Human Sperm Survival Assay - Testing ensures manufacturing materials do not have an adverse effect upon the survival of Human Sperm. Test articles assessed provided acceptable results of ≥ 70% motility at 24 hours.
- Endotoxin Assay (AAMI ST72: 2011 and UPS/NF )