(30 days)
No
The device description and performance studies do not mention any AI or ML components. The device is a simple catheter set for mock embryo transfer.
No
The device is used for a "mock (simulated) embryo transfer procedure" to verify access and positioning of catheters, not for actual therapeutic treatment.
No
The device is a mock transfer catheter used to verify access and positioning for an embryo transfer procedure, not to diagnose a condition or disease. It simulates a procedure rather than providing diagnostic information.
No
The device description clearly outlines physical components made of polyethylene and stainless steel, indicating it is a hardware 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 a "mock (simulated) embryo transfer procedure" to verify catheter access and positioning in advance of an actual embryo transfer. This is a procedural aid, not a diagnostic test performed on a biological sample.
- Device Description: The device is a physical catheter set used for insertion into the uterine cavity. It does not involve the analysis of biological specimens (like blood, urine, tissue, etc.) to provide diagnostic information about a patient's health status.
- Lack of IVD Characteristics: The description does not mention any reagents, assays, or analytical processes typically associated with IVD devices.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device is a tool used in a medical procedure to prepare for another procedure.
N/A
Intended Use / Indications for Use
The Soft-Pass™ Embryo Mock Transfer Catheter Sets are used for mock (simulated) embryo transfer procedures to and in verifying catheter access and positioning in advance of an embryo transfer procedure.
Product codes
MQF
Device Description
The Soft-Pass Embryo Mock Transfer Catheter Sets are used to aid in verifying access and positioning of embryo transfer catheters prior to placing transfer catheters containing embryos into the uterine cavity. These devices consist of a polyethylene guide catheter that is 6.8 Fr in diameter and either 12 or 17.3 cm long, and a polyethylene mock transfer catheter that is 4.4 Fr in diameter and 19.7 or 24.7 cm long. The tip of the mock transfer catheter is closed. The echogenic tip versions of the device also include an echogenic stainless steel band on the distal tip of the mock transfer catheter to aid in tip visualization when using ultrasound. The echogenic tip versions also include a supporting stainless steel cannula in the proximal portion of the mock transfer catheter. Depth markers are also included on both the guide and mock transfer catheters to aid in placement of the device during a mock procedure. These devices are sterilized by ethylene oxide, single-use only, and have a three-year shelf-life.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
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 subject device, Soft-Pass Embryo Mock Transfer Catheter Sets, are identical to those cleared under K173103 and have not undergone any design changes since clearance. The changes in indications for use included in this submission did not require additional performance testing. Therefore, the performance testing included in K173103 supports the Soft-Pass Embryo Mock Transfer Catheter Sets included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 17, 2019
Cook Incorporated Ian Herrman Regulatory Affairs Specialist 750 Daniels Way P.O. Box 489 Bloomington, IN 47402
Re: K191015
Trade/Device Name: Soft-Pass™ Embryo Mock Transfer Catheter Sets (Soft-Pass™ Embryo Mock Transfer Catheter Set and Soft-Pass™ Embryo Mock Transfer Catheter Set with Echogenic Tip) Regulation Number: 21 CFR 884.6110 Regulation Name: Assisted Reproduction Catheters Regulatory Class: Class II Product Code: MQF Dated: April 16, 2019 Received: April 17, 2019
Dear Ian Herrman:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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,
Sharon M. Andrews Assistant Division Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191015
Device Name
Soft-Pass™ Embryo Mock Transfer Catheter Sets (Soft-Pass™ Embryo Mock Transfer Catheter Set and Soft-Pass™ Embryo Mock Transfer Catheter Set with Echogenic Tip)
Indications for Use (Describe)
The Soft-Pass™ Embryo Mock Transfer Catheter Sets are used for mock (simulated) embryo transfer procedures to and in verifying catheter access and positioning in advance of an embryo transfer procedure.
| 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) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY K191015 Soft-Pass™ Embryo Mock Transfer Catheter Sets
| Submitted By: | Cook Incorporated |
|---|---|
| Applicant: | Ian Herrman |
| Contact: | 750 Daniels Way |
| Applicant Address: | P.O. Box 489 |
| Bloomington, IN 47402 | |
| Contact Phone Number: | (812) 339-2235 x104034 |
| Contact Fax Number: | (812) 332-0281 |
| Date Prepared: | May 15, 2019 |
| Device Information: | |
| Trade Names: | Soft-Pass™ Embryo Mock Transfer Catheter Sets |
| (Soft-Pass™ Embryo Mock Transfer Catheter Set and | |
| Soft-Pass™ Embryo Mock Transfer Catheter Set with | |
| Echogenic Tip) | |
| Common Name: | Assisted Reproduction Catheter |
| Regulation Number: | 21 CFR §884.6110 |
| Regulation Name: | Assisted Reproduction Catheters |
| Product Code: | MQF - Catheter, Assisted Reproduction |
| Device Class: | II |
Predicate Device:
K173103 - Pivet and Soft-Pass Embryo Transfer Catheter Sets. Specifically, the Soft-Pass Embryo Mock Transfer Catheter Sets cleared in the predicate submission.
The predicate devices have not been subject to a design-related recall.
Device Description
The Soft-Pass Embryo Mock Transfer Catheter Sets are used to aid in verifying access and positioning of embryo transfer catheters prior to placing transfer catheters containing embryos into the uterine cavity. These devices consist of a polyethylene guide catheter that is 6.8 Fr in diameter and either 12 or 17.3 cm long, and a polyethylene mock transfer catheter that is 4.4 Fr in diameter and 19.7 or 24.7 cm long. The tip of the mock transfer catheter is closed. The echogenic tip versions of the device also include an echogenic stainless steel band on the distal tip of the mock transfer catheter to aid in tip visualization when using ultrasound. The echogenic tip versions also include a supporting stainless steel cannula in the proximal portion of the mock transfer catheter. Depth markers are also included on both the guide and mock transfer catheters to aid in placement of the device during a mock procedure. These devices are sterilized by
4
ethylene oxide, single-use only, and have a three-year shelf-life. The product number and trade name for the subject device sets are presented in the table below.
| Model Number | Trade Name |
|---|---|
| J-SPPE-681200-MC | Soft-Pass™ Embryo Mock Transfer Catheter Set |
| J-SPPE-681700-MC | Soft-Pass™ Embryo Mock Transfer Catheter Set |
| J-SPPE-681210-ET-MC | Soft-Pass™ Embryo Mock Transfer Catheter Set with Echogenic Tip |
| J-SPPE-681710-ET-MC | Soft-Pass™ Embryo Mock Transfer Catheter Set with Echogenic Tip |
Indications for Use
The Soft-Pass™ Embryo Mock Transfer Catheter Sets are used for mock (simulated) embryo transfer procedures to aid in verifying catheter access and positioning in advance of an embryo transfer procedure.
Comparison of Intended Use and Technological Characteristics with the Predicate Device:
| Predicate Device | Subject Device | ||
|---|---|---|---|
| Pivet and Soft-Pass Embryo | |||
| Transfer Catheter Sets | Soft-Pass Embryo Mock | ||
| Transfer Catheter Sets | |||
| 510(k) Number | K173103 (Specifically, the Soft-Pass | ||
| Embryo Mock Transfer Catheter Sets | |||
| with a polyethylene guide catheter, J- | |||
| SPPE-68XXXX-MC[-ET]) | Subject of this submission | ||
| Indications for Use | The Embryo Transfer Catheters/Sets are | ||
| used for transferring IVF embryos into | |||
| the uterine cavity. | The Soft-PassTM Embryo | ||
| Mock Transfer Catheter Sets | |||
| are used for mock (simulated) | |||
| embryo transfer procedures to | |||
| aid in verifying catheter | |||
| access and positioning in | |||
| advance of an embryo | |||
| transfer procedure. | |||
| Material Specification | |||
| Transfer Catheter | Polyethylene, stainless steel (echogenic | ||
| tip versions only), marker ink | Identical | ||
| Guide Catheter | Polyethylene, marker ink | Identical | |
| Physical Characteristics | |||
| Hub | Flared hub on the guide catheter | Identical | |
| Dimensional Data | |||
| Transfer | OD | 4.4 Fr | Identical |
| Catheter | Length | 19.7 cm to 24.7 cm | Identical |
| Guide | OD | 6.8 Fr | Identical |
| Catheter | Length | 12 cm to 17.3 cm | Identical |
| Physical Features | |||
| Transfer | With graduation marks | Identical | |
| No end-hole | Identical |
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| Predicate Device | Subject Device | |
|---|---|---|
| Pivet and Soft-Pass Embryo | ||
| Transfer Catheter Sets | Soft-Pass Embryo Mock | |
| Transfer Catheter Sets | ||
| Guide | With or without Echotip | Identical |
| With graduation marks | Identical | |
| Without positioner | Identical | |
| Without Echotip | Identical | |
| Straight | Identical | |
| Manufacturing Features | ||
| Sterilization | ETO | Identical |
| Packaging | Tyvek Sterile Barrier | Identical |
| Shelf Life | 3 years | Identical |
The purpose of this submission is to modify the indications statement for the Soft-Pass Embryo Mock Transfer Catheter Sets to clarify the cleared uses of these devices. As shown in the table above, the subject and predicate devices have different indications for use statements; however, the intended uses of the predicate and subject devices are the same (i.e., catheter used to aid in embryo transfer procedures).
In regards to technological characteristics, the subject Soft-Pass Embryo Mock Transfer Catheter Sets are identical to those cleared under K173103. There are no differences raising different questions of safety or effectiveness.
Performance Data:
The subject device, Soft-Pass Embryo Mock Transfer Catheter Sets, are identical to those cleared under K173103 and have not undergone any design changes since clearance. The changes in indications for use included in this submission did not require additional performance testing. Therefore, the performance testing included in K173103 supports the Soft-Pass Embryo Mock Transfer Catheter Sets included in this submission.
Conclusion:
The Soft-Pass Embryo Mock Transfer Catheter Sets are substantially equivalent to the predicate devices.