(29 days)
Not Found
No
The device is a chemical buffer solution for cryopreservation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is a buffer solution intended to prevent damage to sperm samples during cryopreservation and thawing, which supports a procedure (IVF) but does not directly treat a disease or condition in a patient.
No
Explanation: The device is described as a buffer intended to prevent damage to sperm samples during cryopreservation and thawing. Its function is to preserve samples, not to diagnose or detect a condition.
No
The device description clearly indicates it is a physical buffer solution provided in glass vials, not a software product.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "prevent damage to sperm samples during cryopreservation and thawing." While it's not directly diagnosing a condition, it is a reagent used in the preparation and handling of a human specimen (sperm) for a medical procedure (IVF).
- Device Description: It is an "aqueous solution intended for use as a buffer to prevent damage to sperm samples during cryopreservation and thawing." This describes a reagent used in a laboratory setting to process a biological sample.
- Context of Use: It is used by an "IVF technician" to "cryopreserve washed spermatozoa." IVF is a medical procedure that involves the manipulation of human gametes in vitro.
- Components: It contains components like glycerol, HEPES, Human Serum Albumin (HSA), and Gentamicin, which are typical components of laboratory reagents used for biological sample handling.
While the device itself doesn't perform a diagnostic test, it is an essential component used in vitro to prepare a human specimen for a medical procedure that is often related to diagnosing and treating infertility. The regulatory definition of an IVD often includes reagents and materials used in the collection, preparation, and examination of specimens taken from the human body.
Therefore, based on its intended use, description, and context of use in an IVF laboratory, the Sydney IVF Sperm Cryopreservation Buffer falls under the category of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Sydney IVF Sperm Cryopreservation Buffer is intended for use as a buffer to prevent damage to sperm samples during cryopreservation and thawing.
Product codes (comma separated list FDA assigned to the subject device)
MQL
Device Description
Sydney IVF Sperm Cryopreservation Buffer consists of an aqueous solution intended for use as a buffer to prevent damage to sperm samples during cryopreservation and thawing. The IVF technician will use the buffer to cryopreserve washed spermatozoa, including MESA (microsurgical epididymal sperm aspiration) and TESA (testicular sperm extraction) samples. Sydney IVF Sperm Cryopreservation Buffer contains glycerol as a cryoprotectant, and HEPES (4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid) as a buffer. This product is used to cryopreserve washed sperm and store them for future use.
Sydney IVF Sperm Cryopreservation Buffer contains Human Serum Albumin (HSA) (4 mg/mL) and Gentamicin (0.01 mg/mL). The device is available as a 20 mL fill only.
The Sydney IVF Sperm Cryopreservation Buffer is provided in glass vials with Fluorotec coated rubber stoppers held in place with a tamper evident seal. These products are single use, sterile (aseptic filtration) devices.
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
IVF technician
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)
The shelf-life of Sydney IVF Sperm Cryopreservation Buffer has been validated in stability studies to 20 weeks at 2 - 8°C. Stability tests included endotoxin, MEA, HSSA, pH, osmolality, HSA and sterility. The results of the testing provide reasonable assurance that the Sydney IVF Sperm Cryopreservation Buffer is as safe and effective as the predicate device and supports a determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other to create a sense of depth and connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 22, 2016
William A. Cook Australia Pty Ltd Gordana Pozvek, Ph.D. Senior Regulatory Affairs Specialist 95 Brandle Street Eight Mile Plains. OLD 4113 Australia
Re: K160814
Trade/Device Name: Sydney IVF Sperm Cryopreservation Buffer Regulation Number: 21 CFR§ 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MOL Dated: March 21, 2016 Received: March 24, 2016
Dear Gordana Pozvek,
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.
1
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 (reporting of medical device-related 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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Benjamin R. Fisher -S
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name Sydney IVF Sperm Cryopreservation Buffer
Indications for Use (Describe)
Sydney IVF Sperm Cryopreservation Buffer is intended for use as a buffer to prevent damage to sperm samples during cryopreservation and thawing.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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3
Attachment 5-2
Image /page/3/Picture/1 description: The image is a logo for Cook Medical. The logo is set against a red background. The word "COOK" is written in large, white, sans-serif letters. Below "COOK" is the word "MEDICAL" in smaller, white letters.
WILLIAM A. COOK AUSTRALIA PTY. LTD 95 BRANDL STREE BRISBANE TECHNOLOGY PARK, EIGHT MILE PLAINS BRISBANE, QLD 4113, AUSTRALIA PHONE: 1800.777.222 FAX: +61.7.3841.1288 WWW.COOKMEDICAL.
510(k) Summary
SUBMITTED BY:
William A. Cook Australia Pty Ltd 95 Brandl Street Eight Mile Plains QLD 4113 Australia
| Contact Person: | Gordana Pozvek Ph.D. |
|---|---|
| Tel: | +61 (7) 3841 1188 |
| Fax: | +61 (7) 3841 3905 |
| E-mail: | Gordana.Pozvek@CookMedical.com |
March 21, 2016 Date Prepared:
DEVICE IDENTIFICATION:
| Trade Name: | Sydney IVF Sperm Cryopreservation Buffer (K-SISC-20) |
|---|---|
| Common Name: | Cryopreservation Solution |
| Regulation No: | 21 CFR 884.6180, Reproductive Media & Supplements |
| Regulatory Class: | II |
| Product Code: | MQL - Media, Reproductive |
PREDICATE DEVICE:
Sydney IVF Sperm Cryopreservation Buffer (K061371), cleared August 17, 2006.
DEVICE DESCRIPTION:
Sydney IVF Sperm Cryopreservation Buffer consists of an aqueous solution intended for use as a buffer to prevent damage to sperm samples during cryopreservation and thawing. The IVF technician will use the buffer to cryopreserve washed spermatozoa, including MESA (microsurgical epididymal sperm aspiration) and TESA (testicular sperm extraction) samples. Sydney IVF Sperm Cryopreservation Buffer contains glycerol as a cryoprotectant, and HEPES (4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid) as a buffer. This product is used to cryopreserve washed sperm and store them for future use.
Sydney IVF Sperm Cryopreservation Buffer contains Human Serum Albumin (HSA) (4 mg/mL) and Gentamicin (0.01 mg/mL). The device is available as a 20 mL fill only.
4
The Sydney IVF Sperm Cryopreservation Buffer is provided in glass vials with Fluorotec coated rubber stoppers held in place with a tamper evident seal. These products are single use, sterile (aseptic filtration) devices.
INDICATIONS FOR USE:
Sydney IVF Sperm Cryopreservation Buffer is intended for use as a buffer to prevent damage to sperm samples during cryopreservation and thawing.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:
Sydney IVF Sperm Cryopreservation Buffer and the predicate device (K061371) have the same fundamental technology and similar technological characteristics including the following:
- Similar chemical formulation
- . Same performance specifications:
- pH 7.3-7.5 ー
- Osmolality 1190 1210 mOsm/kg —
- -Endotoxin