Who is the manufacturer of CRYOPETTE?

Mid-Atlantic Diagnostics, Inc. filed the 510(k) submission for CRYOPETTE (K100596).

What is the FDA product code for CRYOPETTE?

MQK. It is classified under 21 CFR 884.6160 as a Class 2 device in the Obstetrics/Gynecology panel.

What is the regulatory pathway for CRYOPETTE?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like CRYOPETTE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CRYOPETTE

Q: What are the predicate devices for CRYOPETTE?

Irvine Scientific CryoTip (K041562).

K100596 · Mid-Atlantic Diagnostics, Inc. · MQK · Dec 6, 2010 · Obstetrics/Gynecology

Device Facts

Record ID	K100596
Device Name	CRYOPETTE
Applicant	Mid-Atlantic Diagnostics, Inc.
Product Code	MQK · Obstetrics/Gynecology
Decision Date	Dec 6, 2010
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 884.6160
Device Class	Class 2

Indications for Use

The Cryopette is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human blastocyst stage embryos.

Device Story

Cryopette is a cryopreservation storage device for human blastocyst stage embryos. Device consists of a polycarbonate cryostraw with an attached silicone displacement bulb for sample aspiration and dispensing; a metering sheath for rigidity; a support ring; and an outer case for labeling. Used in clinical assisted reproduction laboratories. Operator (embryologist) aspirates sample into straw, heat-seals ends, and plunges device into liquid nitrogen for storage. Post-thaw, device is submerged in 37°C water, cut at the sealing mark, and the bulb is pressed to expel the embryo into warming media. Provides a closed system for vitrification and storage. Benefits include secure containment and maintenance of embryo viability during cryopreservation.

Clinical Evidence

Bench testing only. Mouse Embryo Assay (MEA) demonstrated >70% hatching at 96 hours. Endotoxin levels <20 EU/device. Mechanical testing confirmed aspiration, sealing, and leak-free performance. Comparative testing with predicate (CryoTip) showed equivalent cooling/warming rates and comparable mouse blastocyst survivability (96% for Cryopette vs 84% for CryoTip). Sterilization validation confirmed SAL 10^-6.

Technological Characteristics

Materials: Polycarbonate Lexan OQ-3820 (straw), stainless steel T21-RW (sheath), Black Delrin Acetal Resin (ring), Elastosil LR 3003/20 silicone rubber (bulb), Pebax 6333 (case). Principle: Manual aspiration/dispensing via displacement bulb; heat-sealed closed system. Dimensions: 3.067" overall length. Sterilization: Gamma irradiation (25-35 kGy) per ISO EN552.

Indications for Use

Indicated for use in vitrification procedures to contain and maintain human blastocyst stage embryos.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Irvine Scientific CryoTip (K041562)

Related Devices

K153027 — Cryotop US · Kitazato Biopharma Co., Ltd. · Mar 14, 2016
K112695 — CRYOTOP · Kitazato Biopharma Co;Ltd · Dec 12, 2012
K140072 — CRYOTOP(R) SC · Kitazato Biopharma Co., Ltd. · Apr 3, 2014
K241341 — cryo-GO Vitrification Device · Fujifilm Irvine Scientific · Sep 26, 2024
K172751 — iVitri Straw · Reprobitech Corp. · Feb 9, 2018

Submission Summary (Full Text)

{0}------------------------------------------------ #### 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: l {1}------------------------------------------------ The following testing was performed: - 1. 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. - 2. 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. - 3. 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. - 4. 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. - 5. 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. - 6. 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. - 7. 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. {2}------------------------------------------------ # ADDITIONAL INFORMATION REQUESTED FOR CRYOPETTE 510(k) K100596 ### Substantial Equivalence Comparison | SUBSTANTIAL EQUIVALENCE COMPARISON | MidAtlantic Diagnostics Cryopette (K100596) | Irvine Scientific CryoTip (K041562) | |---------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indication for Use | The Cryopette is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human blastocyst stage embryos. | The CryoTip is a Cryopreservation device that is intended to be used to contain, freeze and maintain oocytes and/or embryos. | | Method of Sterilization | Gamma irradiation 25 -35 kGy according to ISO EN552. | Gamma irradiation 25 -35 kGy according to ISO EN552. | | Sterilization | Microbiological validation of 25kGy Radiation Sterilization by ANSI/AAMI/ISO 11137-2 Method VD max 25 | Validation information not available | | Sterility Assurance Level (SAL) | 10-6 | 10-6 | | Testing- Endotoxin | LAL Method - Each lot of Cryopettes is tested for endotoxin levels. The level of endotoxin units per device must be less than the USP limit of 20EU/device. | LAL Method - Each lot of CryoTips tested for endotoxin levels. The level of endotoxin units per device must be less than the USP limit of 20EU/device. | | Testing - Mouse Embryo Assay | Each lot of Cryopettes is tested using one-cell mouse embryo bioassay. Results must be equal to or greater than 70% to blastocyst stage within 96 hours. | Each lot of CryoTips is tested using one-cell mouse embryo bioassay. Results must be equal to or greater than 70% to blastocyst stage within 96 hours. | | Type of Cryopreservation system | Heat sealing capability allows for a closed system. | Heat sealing capability allows for a closed system. | | | MidAtlantic Diagnostics Cryopette (K100596) | Predicate Device Irvine Scientific CryoTip K041562 | | Blastocyst Survivability (Refer to Feb 2010 Submission) | Overall survival of mouse blastocysts for the Cryopette was 96%. | Overall survival of mouse blastocysts for the Cryotip was 84%. | | Materials | Cryo-Straw: polycarbonate Lexan OQ-3820 Metering Sheath: stainless steel full hard T21-RW Support Ring: Black Delrin Acetal Resin Displacement Bulb: Elastosil LR 3003/20 US Silicon Rubber Outer Case: Pebax 6333 Tubing Adhesive: Loctite 3311 Ink: 18696 Ink Grade (Black) | CryoTip: medical grade plastic Stainless steel cover sleeve | | Mean Sample Volume | 1.08 ul | 1.50 ul | | Loading Method | Samples loaded by gently depressing the displacement bulb to aspirate samples into the Cryo-Straw. | Samples loaded by attaching wide end of CryoTip to aspiration tool such as luer tip syringe using connector. Samples then aspirated into the CryoTip. | | Sample Placement | Sample placement must be | Sample placement should be | | | | between 2nd and 3rd mark of | | | between the Proximal and Distal Storage borders of the Cryopette. | | | | 100% (61/61) of Cryopettes aspirated fluid as intended into the device. None of the Cryopettes experienced any clogging or leaking problems. | 100% (58/58) of Cryotips aspirated fluid as intended into the device. None of the Cryotips experienced any clogging or leaking problems. | | Mechanical Testing | The Cryopette succeeded 100% (61/61) of the time in delivering the specimen to the proper position within the device. | The Cryotip succeeded 100% (58/58) of the time in delivering the specimen to the proper position within the device. | | | Visual confirmation that 100% (61/61) Cryopettes had intact seals and no leakage of fluid. | Visual confirmation that 100% (58/58) Cryotips had intact seals and no leakage of fluid. | | | 100% (61/61) Cryopettes remained intact after removing from liquid nitrogen. | 86% (50/58) Cryotips remained intact after removing from liquid nitrogen; 14% (8/58) Cryotips exploded immediately after removing from liquid nitrogen. | | Dimensions | Cryo-Straw: 2.4" Bulb: .677" Distal end to sealing mark: .206" Sealing mark to Distal Storage border: .394" Distal storage border to proximal storage border: .394" Proximal Storage border to bulb: 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/A N/A I.D of tip: .007" O.D of tip: .07" Overall length: 2.99" | | Dispensing Method Post Thaw | Remove Cryopette® from liquid nitrogen and completely submerge entire | Remove Cryo Tip from liquid nitrogen and immerse into 37 degree Celsius | | | | | | | device into water at 37 degrees Celsius for 5 seconds. Wipe excess water off. Cryopette placed on cutting platform and cut is made just above the heat seal at the Sealing Mark. Displacement Bulb is then pressed to expel blastocyst(s) into vitrification warming media | waterbath and swirl gently for 3 seconds. Wipe Cryo Tip with sterile wipe. Cut seal on wide end of Cryo Tip at Mark # 4. Attach wide end of Cryo Tip to appropriate aspiration tool. Slide metal cover sleeve up to expose tip end of Cryo Tip. Wipe tip with sterile wipe. Cut seal on Mark # 2 and dispense contents utilizing aspiration tool into vitrification warming media. | | Cooling Rate | -23,700 °C/min | -12,000 °C/min | | Vitrification Method | Sealed Cryopette is plunged into a liquid nitrogen reservoir and then placed in a goblet or cryocane. The CryoCane is then stored in a liquid nitrogen freezer for long term storage | Sealed Cryo Tip is plunged into a liquid nitrogen reservoir, metal covered side down, then placed in a goblet or CryoCane. The CryoCane is then stored in a liquid nitrogen freezer for long term storage | | Warming rate | 34,480 °C/min | 24,000 °C/min | {3}------------------------------------------------ # ADDITIONAL INFORMATION REQUESTED FOR CRYOPETTE 510(k) K100596 4 {4}------------------------------------------------ • {5}------------------------------------------------ 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. {6}------------------------------------------------ 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 {7}------------------------------------------------ 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 . {8}------------------------------------------------ # 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

CRYOPETTE

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Indications for Use

Device Story

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Indications for Use

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Predicate Devices

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Submission Summary (Full Text)

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