(249 days)
Not Found
No
The device description and performance studies focus on the chemical composition of media, physical properties of storage devices, and biological outcomes (embryo development), with no mention of computational analysis, algorithms, or data processing that would indicate AI/ML.
No
This device is designed for the vitrification, storage, and warming of oocytes and embryos, which are components of assisted reproductive technology (ART). It does not directly treat a disease or condition in a patient; rather, it is used for ex vivo preservation of biological material.
No
The device description indicates that the Vitrification Kit and Warming Kit are "assisted reproduction technology (ART) media products for freezing and thawing" biological samples. The Cryo-Straw is a "cryopreservation storage device." None of these functions involve diagnosing a condition or disease.
No
The device description clearly outlines physical components (media solutions in vials, cryo-straws) and their physical properties and testing (pH, osmolality, sterilization, dimensions, durability, etc.), indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for the vitrification (freezing) and warming (thawing) of oocytes and embryos for assisted reproduction technology (ART). This is a process performed outside the body to preserve biological material, not to diagnose a condition or provide information about a patient's health status.
- Device Description: The description details media solutions containing cryoprotectants and a storage device (Cryo-straw). These are tools used in a laboratory setting for handling and preserving biological samples, not for analyzing those samples to obtain diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) to detect diseases, conditions, or markers. The process is about preserving the viability of the oocytes and embryos themselves.
- Performance Studies: The performance studies focus on the functionality of the kits and straw for cryopreservation (sterility, shelf-life, embryo development after thawing, physical properties of the straw), not on the accuracy or reliability of a diagnostic test.
- Predicate Device: The predicate device (K171748) is also described as a "Vitrification Kit and Thawing Kit," further supporting the classification of these devices as tools for ART procedures, not IVDs.
In summary, the device is designed to facilitate the process of cryopreserving and thawing oocytes and embryos for reproductive purposes. This falls under the category of medical devices used in assisted reproduction, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Vitrification Kit is indicated for use in the vitrification of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
The Warming Kit is indicated for use in the thawing of vitrified oocvtes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embryos.
The Cryo-straw is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain vitrified oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embrvos.
Product codes
MOL, MOK
Device Description
The Vitrification Kit and Warming Kit are assisted reproduction technology (ART) media products for freezing and thawing oocytes (MII), pronuclear (PN) zygotes through Day 3 cleavage stage embryos, and blastocyst stage embryos.
There are two models for each Vitrification Kit and Warming Kit. The difference is the volume of the solutions in the kits. The solutions in the "A" model for each kit are in 1 ml vials, and the solutions in the "B" model are in 2 ml vials. Each model contains two sets of kit media.
The Vitrification Kit includes three sequential media components, Washing solution (WS), Equilibrium solution (ES), and Vitrification solution (VS), containing the cryoprotectants ethylene glycol, dimethyl sulfoxide, and sucrose. Using this methodology, the permeating cryoprotectants can replace water in the oocyte and PN through blastocyst stage embryos prior to vitrification and storage in liquid nitrogen.
The Warming Kit is composed of three media used sequentially for thawing and removing cryoprotectants from vitrified oocytes and PN through blastocyst stage embryos. The Warming Kit is composed of Thaw solution (TS), Diluent solution (DS), and Washing solution (WS).
All media in the Vitrification Kit and Warming Kit undergo aseptic filtration and are single-use only.
The Cryo-Straw is a single-use, sterile, cryopreservation storage device for holding and maintaining vitrified oocytes (MII) and pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos. There are two models for the Cryo-straws: Type I and Type III, and each has 5 colors: brown, orange, blue, red, green. The Cryo-straws are composed of a rod and sheath with a combined length of 132.5 mm. The Type I model has a flat slide and the Type III model has a curved slide for sample loading. The Cryo-straws are sterilized using gamma radiation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Non-Clinical Performance Data:
Vitrification Kit and Warming Kit:
- Aseptic processing and validation testing that met the requirements of ISO 13408-1:2008/Amd1:2013 and ISO 13408-2:2018.
- Shelf-life testing was conducted to support a 6-month shelf-life for the subject devices through demonstration that the product specifications (shown below) were met at time 0 and after real-time aging:
- pH per USP : 7.2-7.4 for all solutions
- -Osmolality per USP : see the table above for acceptance specifications
- -Endotoxin per USP : : No microbial growth
- Transportation testing per ASTM D4169-22 and cap/seal leak testing using a method equivalent to USP on transportation-conditioned devices.
Cryo-straw:
- The sterilization process and validation methods in accordance with ISO 11737-1:2018, ISO 11737-2:2019, and ISO 11137-3:2017. The sterilization assurance level of the subject device is 10-6.
- . Shelf-life testing was conducted to support a two-year shelf-life for the subject device through demonstration that the product specifications (shown below) were met at time 0 and after real-time aging or accelerated aging in accordance with ASTM F1980-16:
- -Cooling rate: (Type I:1,539°C/min; Type III:1,543°C/min)
- Warming rate: (Type I :21,430°C/min; Type III:21,385°C/min)
- -Dimensional testing
- -Durability: No damage after 30 second immersion in liquid nitrogen
- -Liquid nitrogen penetration: No ingress after 24-hour immersion in liguid nitrogen
- -Endotoxin per USP
§ 884.6180 Reproductive media and supplements.
(a)
Identification. Reproductive media and supplement are products that are used for assisted reproduction procedures. Media include liquid and powder versions of various substances that come in direct physical contact with human gametes or embryos (including water, acid solutions used to treat gametes or embryos, rinsing solutions, sperm separation media, supplements, or oil used to cover the media) for the purposes of preparation, maintenance, transfer or storage. Supplements are specific reagents added to media to enhance specific properties of the media (e.g., proteins, sera, antibiotics, etc.).(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing). The device, when it is phosphate-buffered saline used for washing, and short-term handling and manipulation of gametes and embryos; culture oil used as an overlay for culture media containing gametes and embryos; and water for assisted reproduction applications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
0
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 logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
July 1, 2024
Shandong Wego Ruisheng Medical Device Co., Ltd % Eva Li Consultant Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave. Shanghai. 200122 CHINA
Re: K233477
Trade/Device Name: Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); Vitrification Kit (A-3ML, B-6ML) Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive Media and Supplements Regulatory Class: II Product Code: MOL, MOK Received: May 28, 2024
Dear Eva Li:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
2
Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael T. Bailey -S
For Monica D. Garcia, Ph.D. Assistant 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
3
Indications for Use
510(k) Number (if known) K233477
Device Name Vitrification Kit (A-3ML, B-6ML) Warming Kit (A-4ML, B-8ML) Cryo-straw (Type I, Type III)
Indications for Use (Describe)
The Vitrification Kit is indicated for use in the vitrification of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
The Warming Kit is indicated for use in the thawing of vitrified oocvtes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embryos.
The Cryo-straw is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain vitrified oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embrvos.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(K) Summary K233477
1. Submitter
Shandong Wego Ruisheng Medical Device Co.,Ltd. No. 1 , Weigao Road, Torch High- tech Industrial Development Zone, Weihai, Shandong, China Contact: Yan Tian, R&D Manager Tel: +860631-5713020 Email: y3tian@163.com
2. Date Prepared: July 1, 2024
3. Device
| Trade/Proprietary
Name: | Vitrification Kit (A-3ML, B-6mL)
Warming Kit (A-4ML, B-8mL)
Cryo-straw (Type I, Type III) |
|----------------------------|-------------------------------------------------------------------------------------------------|
| Common Name | Vitrification Cryopreservation Media |
| Regulation | 21 CFR§ 884.6180 |
| Regulation Name | Reproductive Media and Supplements, |
| Product Code | MQL (Media, Reproductive), MQK (Labware, Assisted Reproduction) |
| Classification | Class II |
| Classification panel | Obstetrics/Gynecology |
4. Predicate Device
Vitrification Kit and Thawing Kit from Kitazato Corporation (K171748).
The predicate device has not been subject to a design-related recall.
5. Device Description
The Vitrification Kit and Warming Kit are assisted reproduction technology (ART) media products for freezing and thawing oocytes (MII), pronuclear (PN) zygotes through Day 3
5
Shandong Wego Ruisheng Medical Device Co., LTD. No. 1 , Weigao Road, Torch High-tech Industrial Development Zone, Weihai, Shandong, China cleavage stage embryos, and blastocyst stage embryos.
There are two models for each Vitrification Kit and Warming Kit. The difference is the volume of the solutions in the kits. The solutions in the "A" model for each kit are in 1 ml vials, and the solutions in the "B" model are in 2 ml vials. Each model contains two sets of kit media.
The Vitrification Kit includes three sequential media components, Washing solution (WS), Equilibrium solution (ES), and Vitrification solution (VS), containing the cryoprotectants ethylene glycol, dimethyl sulfoxide, and sucrose. Using this methodology, the permeating cryoprotectants can replace water in the oocyte and PN through blastocyst stage embryos prior to vitrification and storage in liquid nitrogen.
The Warming Kit is composed of three media used sequentially for thawing and removing cryoprotectants from vitrified oocytes and PN through blastocyst stage embryos. The Warming Kit is composed of Thaw solution (TS), Diluent solution (DS), and Washing solution (WS).
All media in the Vitrification Kit and Warming Kit undergo aseptic filtration and are single-use only.
The Cryo-Straw is a single-use, sterile, cryopreservation storage device for holding and maintaining vitrified oocytes (MII) and pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos. There are two models for the Cryo-straws: Type I and Type III, and each has 5 colors: brown, orange, blue, red, green. The Cryo-straws are composed of a rod and sheath with a combined length of 132.5 mm. The Type I model has a flat slide and the Type III model has a curved slide for sample loading. The Cryo-straws are sterilized using gamma radiation.
6. Indication for Use
The Vitrification Kit is indicated for use in the vitrification of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embryos.
The Warming Kit is indicated for use in the thawing of vitrified oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embryos.
The Cryo-straw is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain vitrified oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embryos.
6
7. Substantial Equivalence Discussion
A comparison of the intended use and technological features of the subject and predicate devices are described in the table below:
| Comparison
Item | Subject device
K233477 | Predicate Device
K171748 | Comparison |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K233477 | K171748 | NA |
| Device Name | Vitrification Kit (A-3ML, B-
6mL)
Warming Kit (A-4ML, B-
8mL)
Cryo-straw (Type I, Type III) | Vitrification Kit and
Thawing Kit | NA |
| Indications
for Use | The Vitrification Kit is
indicated for use in the
vitrification of oocytes
(MII), pronuclear (PN)
zygotes through day 3
cleavage stage embryos,
and blastocyst stage
embryos.
The Warming Kit is
indicated for use in the
thawing of vitrified oocytes
(MII), pronuclear (PN)
zygotes through day 3
cleavage stage embryos,
and blastocyst stage
embryos.
The Cryo-straw is a
cryopreservation storage
device that is intended for
use in vitrification
procedures to contain and
maintain vitrified oocytes
(MII), pronuclear (PN) | Vit Kit® - Freeze
(Vitrification Freeze Kit) is
intended for use in the
vitrification of oocytes
(MII), pronuclear (PN)
zygotes through day 3
cleavage stage embryos
and blastocyst stage
embryos.
Vit Kit® - Thaw
(Vitrification Thaw Kit) is
intended for use in the
thawing of oocytes (MII),
pronuclear (PN) zygotes
through day 3 cleavage
stage embryos and
blastocyst stage
embryos. | There are
differences in
the wording of
the indications
for use
statements for
the subject and
predicate
device; however,
the intended
uses of the
subject and
predicate
devices are the
same. |
| | No. 1, Weigao Road, Torch High-tech Industrial Development Zone, Weihai, Shandong, China | | |
| | zygotes through day 3
cleavage stage embryos,
and blastocyst stage
embryos. | | |
| Component | Vitrification Media
Thawing Media
Cryopreservation storage
device | Vitrification Media
Thawing Media
Cryotop
Repro Plate 35 mm dish | Different: The
components of
the subject and
predicate
devices are not
the same.
Differences in
device
components do
not raise
different
questions of
safety and
effectiveness
(S&E). |
| | Media Components | | |
| Vitrification
Formulation | Medium 199 HEPES
Sodium bicarbonate
Sodium pyruvate
Gentamicin sulfate Ethylene
glycol
Dimethyl sulfoxide Sucrose | Medium 199 HEPES
Ethylene glycol
Dimethyl sulfoxide
Trehalose
Hydroxypropyl Cellulose
Gentamicin | Different: The
formulations of
the subject and
predicate
devices are not
the same.
Differences in
device
formulations do
not raise
different
questions of
S&E. |
| Thawing
Formulation | Medium 199 HEPES
Sodium bicarbonate
Sodium pyruvate
Gentamicin sulfate
Sucrose | Medium 199 HEPES
Hydroxypropyl Cellulose
Gentamicin
Trehalose | Different: The
formulations of
the subject and
predicate
devices are not |
Table 1 Comparison of Characteristic
7
| Shandong Wego Ruisheng Medical Device Co., LTD. |
|---|
| No. 1 Weigao Road, Torch High-tech Industrial Development Zone, Weihai Shandong China |
8
| No. 1, Weigao Road, Torch High-tech Industrial Development Zone, Weihai, Shandong, China | |||
|---|---|---|---|
| the same. Differences in device formulations do not raise different questions of safety and effectiveness (S&E). | |||
| Endotoxin | 80% embryos developed to expanded blastocyst within 96 hours | Similar | |
| pH | 7.2-7.4 | 7.2-7.6 | Similar |
| Osmolarity (mOsm/kg) | ES: 1391-1590 (1:1 dilution) | ||
| VS: 1430-1710 (1:3 dilution) | |||
| TS: 1,650-2,170 | |||
| DS: 850-925 | |||
| WS: 265-295 | ES: 2,300-2,800 | ||
| VS: 4,900-6,000 | |||
| TS: 1,600-2,000 | |||
| DS: 830-1020 | |||
| WS/BS: 240-300 | Different: The subject device and predicate devices have differences in osmolality specifications. These differences in osmolality specifications do not raise different questions of S&E. | ||
| Sterilization Method | Aseptic Filtration | Aseptic Filtration | Same |
| Shelf-Life | 6 months | 1 year | Different: The subject device has a shorter shelf-life than the predicate device. |
Shandong Wego Ruisheng Medical Device Co., LTD. No. 1 , Weigao Road, Torch High-tech Industrial Development Zone, Weihai, Shandong, China
9
| No. 1, Weigao Road, Torch High-tech Industrial Development Zone, Weihai, Shandong, China | | | Differences in
shelf-life do not
raise different
questions of S&E |
|------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Storage Device | | | |
| Material
Composition | PETG | ABS, polypropylene,
stainless steel | Different: The
materials of the
subject and
predicate
devices are not
the same.
Differences in
device materials
do not raise
different
questions of
S&E. |
| Design/
Vitrification
Method | Closed vitrification system. | Closed vitrification
system. | Similar |
| | The device consists of a rod
and a sheath. The rod of
Type I Cryo-straw has a flat
slide and the Type III Cryo-
straw has a curved slide,
where the samples are
loaded. | The devices are a two
piece assembly
comprised of a handle
shaft attached to a film
tip, where the samples
are loaded, and a straw
enclosure. | |
| | After samples are loaded,
the slide is inserted into the
pre-cooled sheath to create
a sealed closed system. The
assembled device is stored
in liquid nitrogen (LN). | After samples are loaded,
the film tip is inserted
into the pre-cooled straw
to create a sealed closed
system. The sealed
device is stored in LN. | |
| Device
Dimension | Rod: 118 mm × 2.7 mm
Slide:
- Type I: 16 mm x 0.2 mm
- Type III: 12 mm x 0.24 mm
Sheath: 44 mm | Unknown | Different: The
device
dimension of the
predicate
devices |
| | No. 1, Weigao Road, Torch High-tech Industrial Development Zone, Weihai, Shandong, China | | |
| | - OD: 2.9 mm - ID: 1.95 mm | | unknown.
Differences in
device
dimension do
not raise
different
questions of
S&E. |
| Media Loading
Volume | : 7.2-7.4 for all solutions ।- -Osmolality per USP : see the table above for acceptance specifications
12
Shandong Wego Ruisheng Medical Device Co., LTD.
No.1, Weigao Road, Torch High-tech Industrial Development Zone, Weihai, Shandong, China
- -Endotoxin per USP : : No microbial growth -
- Transportation testing per ASTM D4169-22 and cap/seal leak testing using a method equivalent to USP on transportation-conditioned devices.
Cryo-straw:
- The sterilization process and validation methods in accordance with ISO 11737-1:2018, ISO 11737-2:2019, and ISO 11137-3:2017. The sterilization assurance level of the subject device is 10-6.
- . Shelf-life testing was conducted to support a two-year shelf-life for the subject device through demonstration that the product specifications (shown below) were met at time 0 and after real-time aging or accelerated aging in accordance with ASTM F1980-16:
- -Cooling rate: (Type I:1,539°C/min; Type III:1,543°C/min)
- Warming rate: (Type I :21,430°C/min; Type III:21,385°C/min) -
- -Dimensional testing
- -Durability: No damage after 30 second immersion in liquid nitrogen
- -Liquid nitrogen penetration: No ingress after 24-hour immersion in liguid nitrogen
- -Endotoxin per USP