(87 days)
Not Found
No
The device description focuses on chemical composition and physical properties for sperm processing, with no mention of computational analysis, algorithms, or learning processes.
No.
These devices are used to process sperm for in vitro fertilization procedures, which is a laboratory step, not a direct therapeutic intervention on a patient. While IVF can lead to pregnancy, the device itself is for sperm preparation.
No
The devices are used for processing sperm during in vitro fertilization procedures, specifically for providing a beneficial environment for sperm motility and separating motile sperm. They do not diagnose a disease or condition.
No
The device description clearly outlines physical components (vials, stoppers, seals) and chemical compositions (medium, gradient solutions) which are not software.
Based on the provided text, these devices are not In Vitro Diagnostic (IVD) devices.
Here's why:
- Intended Use: The intended use is explicitly stated as being "during in vitro fertilization procedures to process sperm" and "to separate motile sperm from seminal plasma." This describes a process performed on a biological sample (sperm) outside the body, but the purpose is for a therapeutic procedure (IVF), not for diagnosing a disease or condition.
- Device Description: The description details the composition and function of the media and kits for preparing sperm for fertilization. This aligns with laboratory reagents and tools used in assisted reproductive technology, not diagnostic tests.
- Lack of Diagnostic Claims: There are no mentions of using these devices to detect, measure, or analyze any markers or substances for the purpose of diagnosis, monitoring, or prognosis of a disease or condition.
- Predicate Device: The predicate device listed (K002383) also describes similar products used in IVF procedures, further supporting their classification as devices used in a therapeutic process rather than for diagnosis.
IVD devices are specifically intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality. While these devices are used in vitro with human specimens, their purpose is to prepare the specimen for a therapeutic procedure (IVF), not to provide diagnostic information about the patient's health or condition.
N/A
Intended Use / Indications for Use
Sydney IVF Sperm Medium is intended for use during in vitro fertilization procedures to process sperm.
Sydney IVF Sperm Gradient Kit is intended for use during in vitro fertilization procedures to separate motile sperm from seminal plasma.
Sydney IVF Spermient is intended for use during in vitro fertilization procedures to separate motile sperm from seminal plasma.
Product codes (comma separated list FDA assigned to the subject device)
MQL
Device Description
The Sydney IVF Sperm Medium, Sydney IVF Sperm Gradient Kit and Sydney IVF Spermient are used for processing sperm during in vitro fertilization procedures.
Sperm Medium is used to provide a "liquid" and nutritious environment for the sperm to maintain its motility for the "swim up" procedures and the following fertilization process. The medium contains 10 mg/mL Human Serum Albumin (HSA) and 0.01 mg/mL Gentamicin. It is available in 20, 50 or 100 mL vials.
Sydney IVF Sperm Gradient Kit is used to separate sperm based on density, using density gradient solutions. Sperm Gradient Kit contains both 40% density solutions and is comprised of silane coated silica particles which are diluted in a HEPES buffer. The sperm gradient has the dual purpose of enriching motile sperm populations and removing sperm inhibitory compounds normally present in the eiaculate. It contains 10 mg/mL HSA and 0.01 mg/mL Gentamicin. Sydney IVF Sperm Gradient Kit is available in 20 or 50 mL vials, packaged in a carton box, consisting of one vial filled with the 40% sperm gradient solution, and a second vial filled with the 80% sperm gradient solution.
Sydney IVF Spermient is intended to separate sperm based on density, using density gradient solutions. This is achieved by diluting the Spermient into various concentrations with a HEPES buffered solution. It contains colloidal silica coated with an inert polymer (silane) and has been formulated to be isotonic. Spermient contains 10 mg/mL HSA and 0.01 mg/mL Gentamicin. It is available in 20 or 100 mL vials.
The Sydney IVF Sperm Medium, Sydney IVF Sperm Gradient Kit and Sydney IVF Spermient are 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
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)
The shelf-life of Sydney IVF Sperm Medium, Sperm Gradient Kit and Spermient has been validated in stability studies to 20 weeks at 2 - 8°C. Stability tests included endotoxin, MEA, Human Sperm Survival Assay (HSSA), pH, osmolality, sterility and the concentrations of pyruvate and the HSA by-product ammonia.
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.
0
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 21, 2015
William A. Cook Australia Pty Ltd Gordana Pozvek Senior Regulatory Affairs Specialist 95 Brandl Street Eight Mile Plains QLD 4113 Australia
Re: K152782
Trade/Device Name: Sydney IVF Sperm Medium, Sydney IVF Sperm Gradient Kit, Sydney IVF Spermient Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MOL Dated: November 24, 2015 Received: November 30, 2015
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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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
2
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) K152782
Device Name Sydney IVF Sperm Medium
Indications for Use (Describe)
Sydney IVF Sperm Medium is intended for use during in vitro fertilization procedures to process sperm.
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K152782
Device Name Sydney IVF Sperm Gradient Kit
Indications for Use (Describe)
Sydney IVF Sperm Gradient Kit is intended for use during in vitro fertilization procedures to separate motile sperm from seminal plasma.
| 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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K152782
Device Name Sydney IVF Spermient
Indications for Use (Describe)
Sydney IVF Spermient is intended for use during in vitro fertilization procedures to separate motile sperm from seminal plasma.
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
5
Attachment 5-2
Image /page/5/Picture/1 description: The image shows the Cook Medical logo. The logo is set against a red background. The word "COOK" is written in white, bold, sans-serif font, with the registered trademark symbol next to it. Below "COOK", the word "MEDICAL" is written in white, smaller, sans-serif font.
WILLIAM A. COOK AUSTRALIA PTY. LTD. 95 BRANDL STREET 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 |
Date Prepared: September 22, 2015
DEVICE IDENTIFICATION:
| Trade Name: | Sydney IVF Sperm Medium (Product code: K-SISM) |
|---|---|
| Sydney IVF Sperm Gradient Kit (Product code: K-SISG) | |
| Sydney IVF Spermient (Product code: K-SISP) | |
| Common Name: | Sperm Processing Solutions |
| Regulation No: | 21 CFR 884.6180, Reproductive Media & Supplements |
| Regulatory Class: | II |
| Product Code: | MQL - Media, Reproductive |
PREDICATE DEVICE:
Cook IVF Sperm Buffer, Cook IVF Sperm Medium, and Cook IVF Sperm Gradient Kit (K002383), cleared September 13, 2000.
DEVICE DESCRIPTION:
The Sydney IVF Sperm Medium, Sydney IVF Sperm Gradient Kit and Sydney IVF Spermient are used for processing sperm during in vitro fertilization procedures.
Sperm Medium is used to provide a "liquid" and nutritious environment for the sperm to maintain its motility for the "swim up" procedures and the following fertilization process. The medium contains 10 mg/mL Human Serum Albumin (HSA) and 0.01 mg/mL Gentamicin. It is available in 20, 50 or 100 mL vials.
6
Sydney IVF Sperm Gradient Kit is used to separate sperm based on density, using density gradient solutions. Sperm Gradient Kit contains both 40% density solutions and is comprised of silane coated silica particles which are diluted in a HEPES buffer. The sperm gradient has the dual purpose of enriching motile sperm populations and removing sperm inhibitory compounds normally present in the eiaculate. It contains 10 mg/mL HSA and 0.01 mg/mL Gentamicin. Sydney IVF Sperm Gradient Kit is available in 20 or 50 mL vials, packaged in a carton box, consisting of one vial filled with the 40% sperm gradient solution, and a second vial filled with the 80% sperm gradient solution.
Sydney IVF Spermient is intended to separate sperm based on density, using density gradient solutions. This is achieved by diluting the Spermient into various concentrations with a HEPES buffered solution. It contains colloidal silica coated with an inert polymer (silane) and has been formulated to be isotonic. Spermient contains 10 mg/mL HSA and 0.01 mg/mL Gentamicin. It is available in 20 or 100 mL vials.
The Sydney IVF Sperm Medium, Sydney IVF Sperm Gradient Kit and Sydney IVF Spermient are 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 Medium is intended for use during in vitro fertilization procedures to process sperm.
Sydney IVF Sperm Gradient Kit and Sydney IVF Spermient are intended for use during in vitro fertilization procedures to separate motile sperm from seminal plasma.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:
The Sydney IVF Sperm Medium, Sydney IVF Sperm Gradient Kit & Sydney IVF Spermient, and the predicate device (K002383) have the same fundamental technology and similar technological characteristics including the following:
- . Similar chemical formulation
- . Similar performance specifications:
- Osmolality 285 295 mOsm/kg —
- -Endotoxin