(426 days)
Not Found
No
The device description and performance studies focus on the physical properties and biological outcomes of a cryopreservation straw, with no mention of AI or ML.
No
The device is a cryopreservation storage device for embryos and does not directly provide therapy to a patient. Its function is to preserve embryos for future use in vitrification procedures.
No
The Intended Use and Device Description clearly state that this device is a cryopreservation storage device used for the vitrification (storage at low temperatures) of human embryos. It is not used to identify or determine the nature of a disease or condition.
No
The device description clearly outlines a physical cryopreservation storage device made of polymeric materials (spatula and straw) used to contain and maintain embryos. It describes the physical process of vitrification and thawing using this hardware.
Based on the provided information, the HSV Straw is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "contain and maintain human 4-8 Cell and blastocyst stage embryos" during vitrification procedures. This is a process for preserving biological material, not for diagnosing a condition or providing information about a patient's health status.
- Device Description: The description details a physical device used for cryopreservation and thawing of embryos. It does not involve any reagents, assays, or analytical procedures typically associated with IVDs.
- Lack of Diagnostic Function: The device's function is purely for the physical handling and storage of embryos. It does not analyze biological samples to provide diagnostic information.
- Performance Studies: The performance studies focus on embryo survival rates and device integrity (endotoxin, sterility, mechanical testing), which are relevant to the device's function as a storage and handling tool, not a diagnostic test.
IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The HSV Straw does not perform this function.
N/A
Intended Use / Indications for Use
The HSV Straw is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 Cell and blastocyst stage embryos.
Product codes (comma separated list FDA assigned to the subject device)
MQK
Device Description
An embryo is vitrified using the HSV Straw by placing an embryo suspended in a 0.5ul All entrification solution solution in a curved polymeric spatula (Medical Grade. Styrene-Butadiene Copolymer). The curved spatula is inserted in an outer straw with a Styrene-Butadiene Coporymer). The open, proximal end of the straw is sealed by the user. The sealed, weighted unsal Chd. The open, promishar effect freezing-vitrification. The weighted straw seated straw is placed in liquid nitrogen for embryo storage. Thawing-rewarming: While the remains in liquid nitrogen, part of the outer tube is cut away. The curved spatial, distal tip tellians in inquir mirogen, part of the outer straw and immediately immersed in thawing solution where thawing and dilution of the remaining vitrification solution occur simultaneously.
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)
Clinical use of the HSV Straw was studied in three centers representing diverse approaches to assisted fertility (blastomeres vs blastocysts, multiple embryo transfers vs single embryo transfers, hormone induced cycles vs natural cycles, etc). A total of 473 vitrification cycles using 1509 embryos were captured in the study. Each of the three centers had post vitrification/rewarming embryo % survival of greater than 80%. No device associated adverse effects were experienced by the study sites and the centers continue to routinely use the device. The three centers had high levels of embryo survival after thawing and successfully used the vitrified embryos for pregnancies and live births.
Test data in the submission include mouse embryo assay (MEA), endotoxin and sterility data, mechanical testing, and heating and cooling rate data. MEA testing with mouse blastocysts at 96 hours yielded 90-100% survival and endotoxin testing consistently demonstrated
§ 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.
0
Manufacturer and Submitter
Cryo Bio System 29 Rue Tronchet Paris 75008 FRANCE
Contact Person
Anne Linda van Kappel, MSc, PhD Phone: 33-1-49-24-05-05 FAX: 33-1-49-24-05-01 e-mail: alvk@cryobiosystem-imv.com
DCT 6 2010
Date Prepared: 17 September 2010
Establishment Registration
Cryo Bio System Owner Operator Number: 9042657
Device Trade Name
HSV Straw
Device Generic Name
Cryopreservation straw
Device Classification and Product Code
Class II (Special Controls) per Final Rule, 63FR 48428, Docket number 97N-0335 21 CFR 884, Subpart G, 884.6160 Assisted Reproduction Labware
Product Code: MQK
Indications for Use
The HSV Straw is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 Cell and blastocyst stage embrvos.
Device Description and Principles of Operation for the HSV Straw
An embryo is vitrified using the HSV Straw by placing an embryo suspended in a 0.5ul All entrification solution solution in a curved polymeric spatula (Medical Grade. Styrene-Butadiene Copolymer). The curved spatula is inserted in an outer straw with a Styrene-Butadiene Coporymer). The open, proximal end of the straw is sealed by the user. The sealed, weighted unsal Chd. The open, promishar effect freezing-vitrification. The weighted straw seated straw is placed in liquid nitrogen for embryo storage. Thawing-rewarming: While the remains in liquid nitrogen, part of the outer tube is cut away. The curved spatial, distal tip tellians in inquir mirogen, part of the outer straw and immediately immersed in thawing solution where thawing and dilution of the remaining vitrification solution occur simultaneously.
1
| Attribute | HSV StrawTM,
CryoBio System | Curently marketed,
previously FDA cleared,
cryopreservation device.
CryoTipTM, Irvine
Scientific, Irvine CA | Curently marketed,
previously FDA cleared,
cryopreservation device.
Rapid-iTM, Vitrolife
Sweden AB, Gothenberg,
Sweden |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) # | K092398 | K041562 | K090832 |
| Indications for use | The HSV Straw is a
cryopreservation device
designed to contain, vitrify and
maintain 4-8 cell and blastocyst
stage human embryos. | The CryotipTM is a
cryopreservation device that is
intended to be used to contain,
freeze and maintain oocytes
and/or embryos. | Rapid-iTM is a cryopreservation
device indicated to be used to
contain, vitrify and maintain 4-8
cell stage embryos. |
| Method of action
(vitrification) | An embryo, suspended in a
0.5ul drops of the final
vitrification solution, is placed in
the curved spatula. The curved
spatula is inserted in the outer
straw and the open end of the
straw sealed. The sealed
straw is placed in liquid
nitrogen. | Embryo samples suspended in
the final vitrification solution are
aspirated into a capillary tube
and seals are effected on each
side of the sample.
Subsequently, the tube is
immersed in liquid nitrogen. | Prefreeze a straw with the
open end extending from the
liquid nitrogen. A 10 nanoliter
drop of vitrification solution
holding an embryo is placed in
a capillary sized through hole in
the stick. This, in turn, is
inserted in the pre frozen straw
in liquid nitrogen to effect
freezing of the embryo.
Subsequently, the open end of
the straw is sealed. |
| Cooling Rate1. See
note | 2,900°C/min | 12,000°C/min | 1,220°C/min |
| Method of action
(rewarming) | While the distal tip of the outer
tube remains in liquid nitrogen,
part of the outer tube is cut
away. The curved spatula,
containing the cryopreserved
embryo, is immersed in
thawing solution where thawing
and dilution in the thawing
solution occur simultaneously. | The capillary tube with sample
is removed from liquid nitrogen
and placed in a temperature
controlled solution. After
thawing, the tube is cut open
and the embryo and vitrification
solution are washed out into a
dilution solution. | While the distal end of the
straw remains in liquid
nitrogen, cut the sealed
proximal end of the straw.
Withdraw the stick and directly
immerse the stick/vitrified drop
in warming media. |
| Rewarming Rate1
See note | 25,000°C/min | 41,098°C/min | 7,700°C/min |
| Materials in contact
with tissue
(embryos) | Medical Grade Styrene-
Butadiene Copolymer. | Medical grade polyvinyl
chloride straw. | Polymethyl methacrylate
(PMMA) stick and a poly vinyl
chloride (PVC) straw. |
| Warming: Contact
with the warming
medium | Direct immersion of sample in
the warming solution for
simultaneous thawing and
dilution. | The sealed straw is first
immersed in solution and
warmed/thawed. In a second
step, the thawed sample is
expelled and diluted in the
warming solution. | Direct immersion of sample in
the warming solution for
simultaneous thawing and
dilution. |
Technological Characteristics of the HSV Straw Compared to Predicate Devices
Note: The cooling/heating performance of the CryoTip and HSV devices were determined by laboration in Note: The coolingheating performance of the Cryo rp and 1139 device was interest the publication.
with microminature temperature monitoring. Data for the Rapid-I device used with microminature temperature montioning. Data for na map purification and Warming Embryos Using
Tarankonov et al, 2009, Numerical Simulations Tarankonov et al, 2007, Numerical Unitations Deticles of the Conference 2009, Milan.
the Rapid-i™ Device, Proceedings of the COMSOL Conference 2009, Milan.
Premarket Notification Summary, K092398 Page 2 of 3
2
Substantial Equivalence to Marketed Products
Predicate devices:
Cryotip, Irvine Scientific, Irvine CA, K041562
Rapid-i, Virtrolife Sweden AB, K090832
Clinical use of the HSV Straw was studied in three centers representing diverse approaches to assisted fertility (blastomeres vs blastocysts, multiple embryo transfers vs single embryo transfers, hormone induced cycles vs natural cycles, etc). A total of 473 vitrification cycles using 1509 embryos were captured in the study. Each of the three centers had post vitrification/rewarming embryo % survival of greater than 80%. No device associated adverse effects were experienced by the study sites and the centers continue to routinely use the device. The three centers had high levels of embryo survival after thawing and successfully used the vitrified embryos for pregnancies and live births.
The submission contains information demonstrating substantial equivalence between the devices. Test data in the submission include mouse embryo assay (MEA), endotoxin and sterility data, mechanical testing, and heating and cooling rate data. MEA testing with mouse blastocysts at 96 hours yielded 90-100% survival and endotoxin testing consistently demonstrated Premarket Notification Summary, K092398 Page 3 of 3
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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features an eagle-like bird with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002.
Cryo Bio System % Mr. David Balding Consultant 26552 Tampico Place MISSION VIEJO CA 92691
6 2010
Re: K092398 Trade Name: HSV Straw Regulation Number: 21 CFR $884.6160 Regulation Name: Assisted reproduction labware Regulatory Class: II Product Code: MOK Dated: September 17, 2010 Received: September 21, 2010
Dear Mr. Balding:
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
4
Page 2
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/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 yours,
Hubert Lenoir 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
5
Indications for Use
510(k) Number (if known): K092398
Device Name: HSV Straw
Indications for Use: The HSV Straw is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 Cell and blastocyst stage embryos.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
n Sign-Off) of Reproductive, Gastro-Re · Page of