(279 days)
The Cryopette is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human blastocyst stage embryos.
The Cryopette consists of a cryostraw manufactured from polycarbonate-Lexan OQ-3820. This straw has a displacement bulb attached to one end of the cryostraw whose function is to aspirate and dispense the sample contained in the vitrification media in and out of the opposite (open) end of the cryostraw. The cryostraw is the only sample contacting portion of the Cryopette. The metering sheath provides structural rigidity for the Cryopette. The support ring provides a backstop and seal for the displacement bulb. The outer case encases the displacement bulb to provide a surface for labeling. The sealing mark, distal storage border and proximal storage border reference lines are found on the outside of the cryostraw.
The provided text describes the acceptance criteria and performance data for the Cryopette device. Here's a summary of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mouse Embryo Assay (MEA): >70% hatching at 96 hours | Hatching percentage well exceeded >70% at 96 hours (exact value not specified, but stated as "well exceeded") |
| Endotoxin (LAL) Levels: < 20 EU | Endotoxin levels < 20 EU |
| Mechanical Testing (Aspiration) | Aspirated samples appropriately; 100% (61/61) aspirated fluid as intended; 100% (61/61) delivered specimen to proper position |
| Mechanical Testing (Leakage) | No evidence of leakage following heat sealing; 100% (61/61) had intact seals and no leakage |
| Mechanical Testing (Intact after LN2) | 100% (61/61) remained intact after removing from liquid nitrogen |
| Blastocyst Survivability (Comparative) | Overall survival of mouse blastocysts for the Cryopette was 96% (compared to 84% for predicate) |
| Cooling Rates (Comparative) | -23,700 °C/min (equivalent to predicate device – exact value for predicate: -12,000 °C/min) |
| Warming Rates (Comparative) | 34,480 °C/min (equivalent to predicate device – exact value for predicate: 24,000 °C/min) |
| Sterilization Validation: SAL 10⁻⁶ | SAL of 10⁻⁶ |
| Shelf Life/Package Integrity | Maintained package integrity, sterility, and functionality for labeled shelf life (specific quantitative data not provided) |
2. Sample Size Used for the Test Set and Data Provenance:
- Mouse Embryo Assay (MEA), Endotoxin (LAL) Levels, Sterilization Validation, Shelf Life/Package Integrity: No specific sample sizes for these tests are explicitly stated in the provided text, but it mentions testing is performed "Each lot" for MEA and Endotoxin. The overall performance data pertains to the device's design verification rather than a specific "test set" in the context of an AI/human reader study.
- Mechanical Testing (Aspiration, Leakage, Intact after LN2): 61 Cryopettes were tested.
- Blastocyst Survivability (Comparative Testing): The sample size for the blastocyst survivability study is not explicitly stated in terms of number of blastocysts or replicates, but it compares the "overall survival of mouse blastocysts."
- Heating and Cooling Rates: Not specified.
- Data Provenance: The studies used mouse embryos/blastocysts, suggesting laboratory-based testing rather than clinical retrospective or prospective human data. The precise country of origin is not specified but the submission is for a US FDA 510(k).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This device is a cryopreservation container, and the performance data relates to its physical and biological compatibility characteristics, not a diagnostic interpretation task that would involve human experts establishing ground truth for a test set. The performance is assessed via laboratory assays and mechanical tests.
4. Adjudication Method for the Test Set:
Not applicable, as the data collection does not involve human interpretation or adjudication in the context of diagnostic performance. The results are from objective laboratory tests and direct mechanical observations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of images or other data, which is not the case for a cryopreservation container.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical container, not an algorithm or AI system.
7. The Type of Ground Truth Used:
The "ground truth" for the performance claims is based on:
- Laboratory Assay Results: For Mouse Embryo Assay (embryo viability/hatching), Endotoxin levels.
- Direct Observation/Measurement: For mechanical testing (aspiration, leakage, intactness, dimensions), and sterilization assurance level.
- Comparative Experimental Results: For blastocyst survivability and heating/cooling rates, compared against a predicate device using laboratory experimental setups.
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI/ML algorithm that requires a training set. The descriptions are of device verification and validation tests.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this device.
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510(k) Summary
Submitted by: Mid-Atlantic Diagnostics, Inc.
77 Elbo Lane Mount Laurel, NJ 08054
DEC - 6 2010
Telephone: (856) 762-2000 Facsimile: (856) 762-2009
Contact: Susan Bush, Quality & Regulatory Affairs Manager
Date Submitted: November 8, 2010
Device Identification:
| Trade Name: | Cryopette™ |
|---|---|
| Common Name: | Cryopreservation container |
| Classification Name: | Assisted Reproduction Labware (21 CFR 884.6160) |
| Product Code: | MQK |
Irvine Scientific CryoTip (K041562) Predicate Device:
Description:
The Cryopette consists of a cryostraw manufactured from polycarbonate-Lexan OQ-3820. This straw has a displacement bulb attached to one end of the cryostraw whose function is to aspirate and dispense the sample contained in the vitrification media in and out of the opposite (open) end of the cryostraw. The cryostraw is the only sample contacting portion of the Cryopette.
The metering sheath provides structural rigidity for the Cryopette. The support ring provides a backstop and seal for the displacement bulb. The outer case encases the displacement bulb to provide a surface for labeling.
The sealing mark, distal storage border and proximal storage border reference lines are found on the outside of the cryostraw.
Intended Use:
The Cryopette is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human blastocyst stage embryos.
Performance Data:
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The following testing was performed:
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- Mouse Embryo Assay (MEA): >70% hatching at 96 hours MEA testing was performed to ensure that the Cryopette is nontoxic to embryos. Testing demonstrated that the hatching percentage well exceeded the specification of >70% at 96 hours, and this information will be provided on a Certificate of Analysis accompanying packages of the product.
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- Endotoxin (LAL) Levels: < 20 EU Endotoxin testing was performed to ensure that the Cryopette does not have unacceptable levels of endotoxin. Testing demonstrated that the endotoxin levels are <20 EU, and this information will be provided on a Certificate of Analysis accompanying packages of the product.
-
- Mechanical Testing (Aspiration and Leakage) Mechanical testing, including evaluation of mean, minimum aspiration volumes, as well as leakage following heat sealing of the device, was performed on the Cryopette to ensure that the device functioned as intended. All testing demonstrated that the Cryopette aspirated samples appropriately and did not show evidence of leakage following heat sealing.
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- Blastocyst Survivability (comparative testing to CryoTip predicate device) Comparative testing was performed to demonstrate that mouse blastocysts had comparable survivability following various lengths of storage, compared to the predicate device. This testing demonstrated that mouse blastocysts vitrified and stored in Cryopettes had comparable survivability to mouse blastocysts vitrified and stored in CrvoTips.
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- Heating and Cooling Rates (see table below) An independent laboratory conducted a comparative evaluation of the cooling and warming rates of media in the Cryopette and CryoTip. This testing demonstrated that the cooling and warming rates were equivalent.
-
- Sterilization Validation: SAL 10-6 Sterilization validation was performed to demonstrate that the Cryopette had a SAL of 10 t, and this information will be provided on a Certificate of Analysis accompanying packages of the product.
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- Shelf Life/Package Integrity Shelf life and package integrity testing was performed to demonstrate that the Cryopette maintains package integrity, sterility and functionality for the labeled shelf life of the devices.
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ADDITIONAL INFORMATION REQUESTED FOR CRYOPETTE 510(k) K100596
Substantial Equivalence Comparison
| SUBSTANTIALEQUIVALENCECOMPARISON | MidAtlantic DiagnosticsCryopette (K100596) | Irvine ScientificCryoTip(K041562) |
|---|---|---|
| Indication for Use | The Cryopette is acryopreservation storagedevice that is intended foruse in vitrificationprocedures to contain andmaintain human blastocyststage embryos. | The CryoTip is aCryopreservation devicethat is intended to be used tocontain, freeze and maintainoocytes and/or embryos. |
| Method of Sterilization | Gamma irradiation 25 -35kGy according to ISOEN552. | Gamma irradiation 25 -35kGy according to ISOEN552. |
| Sterilization | Microbiological validation of25kGy RadiationSterilization byANSI/AAMI/ISO 11137-2Method VD max 25 | Validation information notavailable |
| Sterility Assurance Level(SAL) | 10-6 | 10-6 |
| Testing- Endotoxin | LAL Method -Each lot of Cryopettes istested for endotoxin levels.The level of endotoxin unitsper device must be less thanthe USP limit of20EU/device. | LAL Method -Each lot of CryoTips testedfor endotoxin levels. Thelevel of endotoxin units perdevice must be less than theUSP limit of 20EU/device. |
| Testing - Mouse EmbryoAssay | Each lot of Cryopettes istested using one-cell mouseembryo bioassay. Resultsmust be equal to or greaterthan 70% to blastocyst stagewithin 96 hours. | Each lot of CryoTips istested using one-cell mouseembryo bioassay. Resultsmust be equal to or greaterthan 70% to blastocyst stagewithin 96 hours. |
| Type ofCryopreservationsystem | Heat sealing capabilityallows for a closed system. | Heat sealing capabilityallows for a closed system. |
| MidAtlantic DiagnosticsCryopette (K100596) | Predicate Device IrvineScientific CryoTip K041562 | |
| BlastocystSurvivability (Refer to Feb2010 Submission) | Overall survival of mouseblastocysts for the Cryopettewas 96%. | Overall survival of mouseblastocysts for the Cryotipwas 84%. |
| Materials | Cryo-Straw: polycarbonateLexan OQ-3820Metering Sheath: stainlesssteel full hard T21-RWSupport Ring: Black DelrinAcetal ResinDisplacement Bulb: ElastosilLR 3003/20 US SiliconRubberOuter Case: Pebax 6333TubingAdhesive: Loctite 3311Ink: 18696 Ink Grade(Black) | CryoTip: medical gradeplasticStainless steel cover sleeve |
| Mean Sample Volume | 1.08 ul | 1.50 ul |
| Loading Method | Samples loaded by gentlydepressing the displacementbulb to aspirate samples intothe Cryo-Straw. | Samples loaded by attachingwide end of CryoTip toaspiration tool such as luertip syringe using connector.Samples then aspirated intothe CryoTip. |
| Sample Placement | Sample placement must be | Sample placement should be |
| between 2nd and 3rd mark of | ||
| between the Proximal andDistal Storage borders of theCryopette. | ||
| 100% (61/61) of Cryopettesaspirated fluid as intendedinto the device. None of theCryopettes experienced anyclogging or leakingproblems. | 100% (58/58) of Cryotipsaspirated fluid as intendedinto the device. None of theCryotips experienced anyclogging or leakingproblems. | |
| Mechanical Testing | The Cryopette succeeded100% (61/61) of the time indelivering the specimen tothe proper position withinthe device. | The Cryotip succeeded100% (58/58) of the time indelivering the specimen tothe proper position withinthe device. |
| Visual confirmation that100% (61/61) Cryopetteshad intact seals and noleakage of fluid. | Visual confirmation that100% (58/58) Cryotips hadintact seals and no leakageof fluid. | |
| 100% (61/61) Cryopettesremained intact afterremoving from liquidnitrogen. | 86% (50/58) Cryotipsremained intact afterremoving from liquidnitrogen; 14% (8/58)Cryotips explodedimmediately after removingfrom liquid nitrogen. | |
| Dimensions | Cryo-Straw: 2.4"Bulb: .677"Distal end to sealing mark:.206"Sealing mark to DistalStorage border: .394"Distal storage border toproximal storage border:.394"Proximal Storage border tobulb: 1.406"I.D. of Bulb: .028"O.D of Bulb: .128"I.D. of Straw: .0100"O.D of Straw: .0150"Overall length: 3.067" | N/AN/AI.D of tip: .007"O.D of tip: .07"Overall length: 2.99" |
| Dispensing Method PostThaw | Remove Cryopette® fromliquid nitrogen andcompletely submerge entire | Remove Cryo Tip fromliquid nitrogen and immerseinto 37 degree Celsius |
| device into water at 37degrees Celsius for 5seconds.Wipe excess water off.Cryopette placed on cuttingplatform and cut is madejust above the heat seal atthe Sealing Mark.Displacement Bulb is thenpressed to expel blastocyst(s)into vitrification warmingmedia | waterbath and swirl gentlyfor 3 seconds.Wipe Cryo Tip with sterilewipe.Cut seal on wide end of CryoTip at Mark # 4.Attach wide end of Cryo Tipto appropriate aspirationtool.Slide metal cover sleeve upto expose tip end of CryoTip.Wipe tip with sterile wipe.Cut seal on Mark # 2 anddispense contents utilizingaspiration tool intovitrification warming media. | |
| Cooling Rate | -23,700 °C/min | -12,000 °C/min |
| Vitrification Method | Sealed Cryopette is plungedinto a liquid nitrogenreservoir and then placed ina goblet or cryocane.The CryoCane is then storedin a liquid nitrogen freezerfor long term storage | Sealed Cryo Tip is plungedinto a liquid nitrogenreservoir, metal covered sidedown, then placed in agoblet or CryoCane.The CryoCane is then storedin a liquid nitrogen freezerfor long term storage |
| Warming rate | 34,480 °C/min | 24,000 °C/min |
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ADDITIONAL INFORMATION REQUESTED FOR CRYOPETTE 510(k) K100596
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Discussion of Similarities/Differences: Overall the Cryopette and CryoTip are very similar Divices. Each consists of a Cryo-Straw with nearly identical dimensions and volume capacity. Each has a mechanism to aspirate fluid into the Cryo-Straw, heat seal the open ends of the Cryo-Straw, plunge the closed device into liquid nitrogen, and stored onto a CryoCane. The main two differences include the aspiration methods and the presence or absence of an outer metal sheath. The Cryopette has a built-in silicone bulb used to aspirate fluid into the Cryo-Straw whereas the CryoTip uses a detachable syringe. Both aspirate nate the the of the same volume of fluid just in a slightly different manner. The acriees aspirate roughty outer metal sheath that slides over the Cryo-Straw while being handled in storage whereas the Cryopette is stored without a metal cover. Mechanical testing to include Mouse Blastocyst Survival data demonstrate that each device consistently testing to include infouse masteryst bell as survival of blastocysts following vitrification and warming.
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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes across its body, representing the department's commitment to promoting health and well-being. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
DEC - 6 2010
Origio MidAtlantic Devices c/o Elisa D. Harvey, DVM, PhD Senior Regulatory Consultant CardioMed Device Consultants, LLC 18905 Celebrity Lane SANDY SPRING MD 20860
Re: K100596 Trade Name: Cryopette® Regulation Number: 21 CFR $884.6160 Regulation Name: Assisted reproduction labware Regulatory Class: II Product Code: MOK Dated: November 18, 2010 Received: November 23, 2010
Dear Dr. Harvey:
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-related
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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours,
Hubert Lemur MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure .
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ADDITIONAL INFORMATION REQUESTED FOR CRYOPETTE 510(k) K100596
Indications for Use
510(k) Number (if known): K100596 Device Name: Cryopette® Indications for Use:
DEC - 6 2010
The Cryopette is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human blastocyst stage embryos.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over-the-counter use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K100596
§ 884.6160 Assisted reproduction labware.
(a)
Identification. Assisted reproduction labware consists of laboratory equipment or supplies intended to prepare, store, manipulate, or transfer human gametes or embryos for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures. These include syringes, IVF tissue culture dishes, IVF tissue culture plates, pipette tips, dishes, plates, and other vessels that come into physical contact with gametes, embryos or tissue culture media.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when it is a dish or plate intended for general assisted reproduction technology procedures, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.