(264 days)
Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, and Soft -Trans Malleable Obturator:
Used to supplement and assist uterine access of a cleared, dimensionally compatible embryo transfer device for placement of in vitro fertilized (IVF) embryos into the uterine cavity.
GuardiaTM ETS Embryo-Tested Syringe:
For use with catheters indicated for intrauterine insemination and embryo transfer.
Flushing Catheter:
The Flushing Catheter is intended for instillation of sterile medium into the cervical canal prior to embryo transfer.
This 510(k) covers eight devices from five of COOK's device families. These devices, as outlined in the table below, are sold separately.
The polyurethane obturators are designed to fit dimensionally compatible embryo transfer guide catheters. Some of these devices are designed to be adjustable in length.
The flushing catheter is a 20 cm tube measuring 14.9 Fr at the proximal end and tapering to 3.5 Fr at the distal end. It features a depth indicator and directional side port with an ink mark aligned with the position of the side port. This device is identical to the Insemi-Cath IUI catheter cleared under K172321.
The Guardia Embryo-Tested Syringe is two-part syringe with a polypropylene barrel and a highdensity polyethylene plunger. This device undergoes Mouse Embryo Assay (MEA) and endotoxin testing (LAL) before lot release.
All subject devices are supplied sterile and intended for one-time use. The Guardia Embryo-Tested Syringe has a shelf-life of five years, whereas the remaining subject devices have a shelflife of three years.
The Cook Incorporated K180302 submission describes several devices, including Obturators, an Embryo-Tested Syringe, and a Flushing Catheter. The acceptance criteria and supporting studies are primarily focused on the physical and biological characteristics of these devices rather than a comparative performance study with human readers or AI.
1. Acceptance Criteria and Reported Device Performance
The provided document lists acceptance criteria and reported performance for several non-clinical tests.
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sterilization Validation | Per ISO 11135-1:2007 (Specific acceptance criteria not detailed, but implied by standard) | Testing performed per ISO 11135-1:2007 |
| Biocompatibility | Per ISO 10993-5:2009 for Cytotoxicity, ISO 10993-10:2002/2010 for Sensitization & Intracutaneous Irritation (Specific acceptance criteria not detailed, but implied by standards) | Studies performed for Cytotoxicity, Guinea Pig Maximization Sensitization, and Intracutaneous Irritation. |
| Endotoxin Testing | <20 EU/device per AAMI/ANSI ST72:2011 | Testing performed per AAMI/ANSI ST72:2011 |
| Transportation Simulation | Per ASTM D4169-05 (Specific acceptance criteria not detailed, but implied by standard) | Study performed per ASTM D4169-05 |
| Package Integrity | Bubble Leak Test per ASTM F2096-04, Seal Strength per ASTM F88-09, No visual damage | Performed after real-time aging: Bubble Leak test per ASTM F2096-04, Seal Strength testing per ASTM F88-09, Visual Inspection showed no package damage (tears, folds, puncture holes, etc.) |
| Mouse Embryo Assay (MEA) | 1-cell MEA >80% embryos developed to blastocyst in 96 hours | Achieved: "The testing demonstrated that the devices met acceptance criterion of '1-cell MEA >80% embryos developed to blastocyst in 96 hours.'" |
| Bench Performance (General) | All predetermined acceptance criteria were met | Demonstrated that all predetermined acceptance criteria were met in the following tests before and after aging: |
| - Obturator/Flushing Catheter Dimensional Verification | Devices measured and verified against device input requirements (Actual criteria not specified) | Devices are measured and verified against device input requirements. |
| - Flushing Catheter Leak Test | Fluid path does not leak under a predetermined injection pressure (Actual pressure not specified) | Testing ensures that fluid path does not leak under a predetermined injection pressure. |
| - Obturator/Flushing Catheter Tensile Test | Tensile strength value is greater than the predetermined acceptance criterion (Actual value not specified) | Testing demonstrates that the tensile strength value is greater than the predetermined acceptance criterion. |
| - Obturator Handle Securement Test | Adjustment mechanism does not allow the obturator to move from its set position under worst case handling (Specific conditions not detailed) | Testing demonstrates the adjustment mechanism does not allow the obturator to move from its set position under worst case handling under the predetermined acceptance criterion. |
| - Obturator Fracture Test | Test articles do not fracture, loosen, or fail when tested in accordance with ISO 11070:1999 | This testing demonstrated that the test articles do not fracture, loosen, or fail when tested in accordance with ISO 11070:1999 |
2. Sample Size for Test Set and Data Provenance
The document does not specify the exact sample sizes used for each individual non-clinical test (e.g., number of devices tested for tensile strength or leak tests). The studies are laboratory-based and conducted by the manufacturer, Cook Incorporated, in the United States. They appear to be prospective in nature, as they involve testing newly manufactured devices against established criteria.
3. Number of Experts and Qualifications for Ground Truth
This type of device (assisted reproduction catheters and obturators) does not typically involve human expert interpretation of images or data for establishing ground truth in the same way an AI diagnostic device would. The "ground truth" here is defined by physical performance characteristics, biological safety, and adherence to engineering specifications and international standards. Therefore, information about the number or qualifications of experts for establishing ground truth in this context is not applicable and not provided in the document.
4. Adjudication Method for Test Set
Given that the tests are primarily objective measurements of physical and biological properties against predefined specifications and standards, an adjudication method (like 2+1 or 3+1 used in clinical studies with subjective interpretations) is not applicable. The results are typically pass/fail based on direct measurement or observation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The device is a physical medical instrument, not a diagnostic AI device that assists human readers. Therefore, the effect size of how much human readers improve with AI vs. without AI assistance is not relevant or measured.
6. Standalone Performance Study
A standalone performance study (algorithm only without human-in-the-loop) is not applicable here as the device is not an algorithm or an AI system. The performance studies described are essentially "standalone" in that they test the device's physical and biological properties directly.
7. Type of Ground Truth Used
The ground truth for these tests is based on:
- Engineering Specifications: Device input requirements for dimensions, material properties, and functional performance (e.g., leak resistance, tensile strength, securement).
- International Standards: e.g., ISO 11135-1:2007 for sterilization, ISO 10993-5/10 for biocompatibility, AAMI/ANSI ST72:2011 for endotoxin, ASTM D4169-05 for transportation, ASTM F2096-04 and F88-09 for package integrity, ISO 11070:1999 for fracture testing.
- Biological Activity: The Mouse Embryo Assay (MEA) uses the development of embryos to the blastocyst stage as an objective biological measure of non-toxicity.
8. Sample Size for the Training Set
"Training set" is not applicable as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned for this device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 24, 2018
Cook Incorporated Naomi Funkhouser Regulatory Affairs Specialist 750 Daniels Way P.O. Box 489 Bloomington, Indiana 47402
Re: K180302
Trade/Device Name: Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, Soft-Trans Malleable Obturator, Guardia™ ETS Embryo-Tested Syringe, Flushing Catheter Regulation Number: 21 CFR 884.6110 Regulation Name: Assisted Reproduction Catheters Regulatory Class: Class II Product Code: MOF Dated: September 26, 2018 Received: September 27, 2018
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. 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 (OS) 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 -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
510(k) Number (if known) K180302
Device Name
Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, Soft -Trans Malleable Obturator, GuardiaTM ETS Embryo-Tested Syringe, Flushing Catheter
Indications for Use (Describe)
Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, and Soft -Trans Malleable Obturator:
Used to supplement and assist uterine access of a cleared, dimensionally compatible embryo transfer device for placement of in vitro fertilized (IVF) embryos into the uterine cavity.
GuardiaTM ETS Embryo-Tested Syringe:
For use with catheters indicated for intrauterine insemination and embryo transfer.
Flushing Catheter:
The Flushing Catheter is intended for instillation of sterile medium into the cervical canal prior to embryo transfer.
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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Image /page/3/Picture/0 description: The image shows the Cook Medical logo. The logo consists of the word "COOK" in white, bold letters on a red background. Below the word "COOK" is the word "MEDICAL" in white letters on a red background. The red background is shaped like a rectangle with a notch cut out of the upper left corner.
510(k) Summary - K180302
1. Submitter Information:
| Applicant: | Cook Incorporated |
|---|---|
| Contacts: | Naomi FunkhouserRohini Patel |
| Applicant Address: | Cook Incorporated750 Daniels WayBloomington, IN 47404 |
| Contact Phone: | (812) 339-2235 x104371 |
| Contact Fax: | (812) 332-0281 |
| 2. Date Prepared: | October 24, 2018 |
| 3. Device Information: | |
| Trade Names: | Guardia™ Access Malleable Obturator, Guardia™Obturator, Soft-Pass™ Obturator, Soft-Trans MalleableObturator, Guardia™ ETS Embryo-Tested Syringe,Flushing Catheter |
| Common Name: | Embryo Transfer Obturators and Accessories |
| Classification Name: | Assisted Reproduction Catheters (21 CFR 884.6110) |
| Classification Regulation: | MQF (Catheter, Assisted Reproduction) |
| Regulatory Class | II |
4. Predicate Device:
Embryo Transfer Catheter/Sets (K983594) manufactured by Cook Ob/Gyn. This predicate device has not been subject to any design related recalls.
5. Device Description:
This 510(k) covers eight devices from five of COOK's device families. These devices, as outlined in the table below, are sold separately.
| Product family | Product name | RPN | Diameter/length or volume |
|---|---|---|---|
| Guardia Access | Guardia™ Access MalleableObturator | K-JET-7002 | 4.0 Fr/19.9 cm |
| Guardia | Guardia™ Obturator (MalleableAdjustable Obturator) | J-UOB-2828 | 2.8 Fr/28 cm |
| Guardia™ Obturator (MalleableAdjustable Obturator) | J-UOB-4028 | 4.0 Fr/28 cm |
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Image /page/4/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, sans-serif font, placed on a red square. Below the red square is a red banner with the word "MEDICAL" in white, sans-serif font. The banner is slightly offset from the square above it.
| Guardia™ Obturator (Stiff AdjustableObturator) | J-UOB-4028-ST | 4.0 Fr/28 cm | |
|---|---|---|---|
| Guardia™ ETS Embryo-TestedSyringe | K-ETS-1000 | 1 ml | |
| Soft-Pass | Soft-Pass™ Obturator | J-SP-4420 | 4.4 Fr/20.2 cm |
| Soft-Trans | Soft-Trans Malleable Obturator | K-SOFT-4018 | 4.0 Fr/18 cm |
| Flushing Catheter | Flushing Catheter | J-IUIC-352000-CE | 3.5 Fr/20 cm |
The polyurethane obturators are designed to fit dimensionally compatible embryo transfer guide catheters. Some of these devices are designed to be adjustable in length.
The flushing catheter is a 20 cm tube measuring 14.9 Fr at the proximal end and tapering to 3.5 Fr at the distal end. It features a depth indicator and directional side port with an ink mark aligned with the position of the side port. This device is identical to the Insemi-Cath IUI catheter cleared under K172321.
The Guardia Embryo-Tested Syringe is two-part syringe with a polypropylene barrel and a highdensity polyethylene plunger. This device undergoes Mouse Embryo Assay (MEA) and endotoxin testing (LAL) before lot release.
All subject devices are supplied sterile and intended for one-time use. The Guardia Embryo-Tested Syringe has a shelf-life of five years, whereas the remaining subject devices have a shelflife of three years.
6. Indications for Use:
Guardia Malleable Obturator, Guardia TM Obturator, Soft-Pass™ Obturator, and Soft-Trans Malleable Obturator:
Used to supplement and assist uterine access of a cleared, dimensionally compatible embryo transfer device for placement of in vitro fertilized (IVF) embryos into the uterine cavity.
GuardiaTM ETS Embryo-Tested Syringe
For use with catheters indicated for intrauterine insemination and embryo transfer.
Flushing Catheter
The Flushing Catheter is intended for instillation of sterile medium into the cervical canal prior to embryo transfer.
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Image /page/5/Picture/0 description: The image shows the Cook Medical logo. The word "COOK" is in white, sans-serif font on a red background. Below the word "COOK" is the word "MEDICAL" in white, sans-serif font on a red background. The red background is shaped like a rectangle with a diagonal cut on the bottom left.
7. Comparison of Intended Use and Technological Characteristics with the Predicate Device:
Comparison of obturators with the predicate device
| Device | Subject device (K180302) | Predicate device (K983594) |
|---|---|---|
| Intended Use | Same as the predicate device | Used to supplement and assist uterine access ofcleared, dimensionally compatible embryo transferdevices for placement of in vitro fertilized (IVF)embryos into the uterine cavity. |
| Design | • Adjustable handles to be sizedto fit inside guide catheters• Polyethylene over softstainless or stylet wire formalleability• Smooth and rounded distal tip | • Sized to fit inside guide catheters• Malleability not specified• Tip characteristic not specified |
| Dimension | • OD: 2.8-4.4 Fr• Length: 18-28 cm | • OD: Matched to fit within guide catheter• Length: matched with guide catheter at tip |
| Materials | Same as the predicate device | Polyethylene, stainless steel |
Both subject and predicate devices are used to supplement and assist uterine access of cleared, dimensionally compatible embryo transfer devices for placement of IVF embryos into the uterine cavity. Therefore, they have the same intended use.
The subject and predicate devices use the same materials but have different design and dimensions. However, the differences are commonly seen in cleared devices and therefore, do not raise different questions of safety and effectiveness. The differences can be assessed by biocompatibility and bench performance testing.
Comparison of Guardia™ ETS Embryo-Tested Syringe with the predicate device
The predicate device (K983594) includes a syringe intended for aiding in embryo transfer procedures. Therefore, the subject device and predicate devices have the same intended use. In addition, these two devices have comparable technological characteristics. The Guardia™ ETS Embryo-Tested Syringe is identical to a cleared device intended for general injection use. To ensure biological safety, the subject syringe is evaluated for embryotoxicity and endotoxin.
| Device | Subject device (K180302) | Predicate device (K983594) |
|---|---|---|
| Design | • Without graduation marks• Close end with side port• Without hubs• With positioner | • With or without graduation marks• Open end with side port• With or without hubs• Without positioner |
| Dimension | OD 3.5 Fr / Length 20 cm | OD 2-8 Fr / Length 12-30 cm |
| Materials | Nylon, silicone | Polyethylene, Teflon, stainless steel |
Comparison of Flushing Catheter with the predicate device
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Image /page/6/Picture/0 description: The image shows the Cook Medical logo. The logo consists of the word "COOK" in white, sans-serif font, stacked on top of the word "MEDICAL" in a smaller, white, sans-serif font. Both words are set against a red background. The "COOK" has a trademark symbol next to it.
The subject and predicate devices have similarity in design (e.g., side port, hubless, no graduation marks and comparable dimensions). There are differences in design, materials, and dimensions, but these differences do not raise different questions of safety or effectiveness as compared to the predicate device and are commonly seen in other comparable cleared Assisted Reproduction Technology devices. The differences can be assessed by biocompatibility and bench performance testing.
8. Summary of Non-Clinical Performance Testing:
The following studies have been performed to support substantial equivalence to the predicate device:
- . Sterilization Validation testing per ISO 11135-1:2007
- . Biocompatibility studies, as follows:
- Cytotoxicity testing per 10993-5:2009 o
- Guinea Pig Maximization Sensitization testing per ISO 10993-10:2002/2010 o
- Intracutaneous Irritation testing per ISO 10993-10:2002/2010 o
- Endotoxin testing per AAMI/ANSI ST72:2011 (<20 EU/device) .
- Transportation Simulation study per ASTM D4169-05 .
- Package Integrity testing after real-time aging: ●
- Bubble Leak test per ASTM F2096-04 o
- Seal Strength testing per ASTM F88-09 o
- Visual Inspection: No package displayed damage (tears, folds, puncture holes, etc.) o
- Mouse Embryo Assay (MEA) before and after aging:
One-cell mouse embryos were exposed to subject devices and cultured at 37°C in an atmosphere containing 5% CO2. The percent of embryos developed to the expanded blastocyst stage within 96 hours were assessed. The testing demonstrated that the devices met acceptance criterion of "1-cell MEA >80% embryos developed to blastocyst in 96 hours."
- Bench Performance studies before and after aging demonstrated that all predetermined acceptance criteria were met in the following tests:
- Obturator/Flushing Catheter dimensional verification Devices are measured and o verified against device input requirements.
- Flushing Catheter Leak Test Testing ensures that fluid path does not leak under a o predetermined injection pressure.
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Image /page/7/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, block letters on a red background. Below the word "COOK" is the word "MEDICAL" in white, block letters on a red background. The red background extends further to the left than the word "COOK".
- Obturator/Flushing Catheter Tensile Test Testing demonstrates that the tensile o strength value is greater than the predetermined acceptance criterion.
- Obturator Handle Securement Test Testing demonstrates the adjustment o mechanism does not allow the obturator to move from its set position under worst case handling under the predetermined acceptance criterion.
- Obturator Fracture Test This testing demonstrated that the test articles do not o facture, loosen, or fail when tested in accordance with ISO 11070:1999
In addition, performance data in K172321 and K101547 are leveraged to support substantial equivalence of Flushing Catheter and Guardia™ ETS Embryo-Tested Syringe, respectively.
9. Conclusion:
The subject and predicate devices have the same intended use. Although there are differences in technological characteristics between the subject and predicate devices, these differences do not raise different questions of safety or effectiveness. The performance data demonstrate that the subject devices are substantially equivalent to the predicate device.
§ 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).