(142 days)
ORIGIO® Sequential Fert™ is for the fertilization of oocytes in vitro.
ORIGIO® Sequential Cleav™ is for the culture of embryos until the 2-8 cell stage. ORIGIO® Sequential Cleav™ can also be used for embryo transfer at day 2 or 3.
ORIGIO® Sequential Fert™ and ORIGIO® Sequential Cleav™ are aseptically filtered, non viscous solutions, light pink or colorless solutions, which are ready to use by professionals within assisted reproduction.
ORIGIO® Sequential Fert™ and ORIGIO® Sequential Cleav™ are contained in 10 mL or 60 mL transparent polyethylene terephthalate glycol (PETG) bottles with high density polyethylene (HDPE) closures, available in card board boxes of 1 x 10 mL and 1 x 60 mL bottles. The bottles and boxes are individually labeled. The boxes also contain instruction for use provided as package insert.
This document describes the ORIGIO® Sequential Fert™ and ORIGIO® Sequential Cleav™ medical devices. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets acceptance criteria from a standalone clinical study.
Therefore, a table of "acceptance criteria" and "reported device performance" specifically for the device's diagnostic performance (like sensitivity/specificity) is not provided in the typical sense of a diagnostic medical device. Instead, the "acceptance criteria" are implied by the comparison to predicate devices' specifications and functional properties through various laboratory tests.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally expressed as ranges or thresholds for various physicochemical properties and biological performance in comparison to predicate devices and recognized ART media. The reported device performance is stated to meet these specifications.
| Characteristic | Acceptance Criteria (ORIGIO® Sequential Fert™) | Reported Device Performance (ORIGIO® Sequential Fert™) | Acceptance Criteria (ORIGIO® Sequential Cleav™) | Reported Device Performance (ORIGIO® Sequential Cleav™) |
|---|---|---|---|---|
| pH | 7.3-7.5 | Meets specification (implied) | 7.2-7.4 | Meets specification (implied) |
| Osmolality (mOsm/kg) | 277-293 | Meets specification (implied) | 272-288 | Meets specification (implied) |
| Endotoxin (EU/mL) | <0.15 | Meets specification (implied, better than predicate) | <0.15 | Meets specification (implied, better than predicate) |
| Aseptically filtered | X | Meets specification (implied) | X | Meets specification (implied) |
| 1-cell MEA (Mouse Embryo Assay) | ≥80% | ≥80% | ≥80% | ≥80% |
| Sterility | Sterile | Meets specification (implied) | Sterile | Meets specification (implied) |
| HSA Concentration | Stable through shelf life | Meets specification (implied) | Stable through shelf life | Meets specification (implied) |
| Biocompatibility | Cytotoxicity, sensitization, and irritation tests demonstrate biocompatibility (for ORIGIO® Sequential Cleav™ only) | Biocompatible (for short duration contact with mucosal tissues) | N/A | N/A |
| Shelf Life | 36 weeks | Validated to 36 weeks | 36 weeks | Validated to 36 weeks |
Note: The document does not provide specific numerical "reported device performance" results for pH, osmolality, endotoxin, or sterility, but states that these parameters were tested and met specifications or were comparable to predicate devices. For MEA, the specific percentage is given as >=80% in the table, implying this was maintained.
2. Sample size used for the test set and the data provenance
The document does not describe a clinical "test set" in the context of diagnostic device performance (e.g., patient data for sensitivity/specificity). Instead, the "testing" refers primarily to:
- Physicochemical analyses: pH, osmolality, endotoxin, sterility performed on batches of the manufactured media. The sample size for these manufacturing release tests is not specified but would typically follow internal quality control procedures.
- Mouse Embryo Assay (MEA): This is a biological test performed on mouse embryos to assess the media's ability to support embryo development. The sample size for MEA is stated as achieving "≥80%," indicating a pass/fail criterion rather than a detailed study sample size. The provenance of these mouse embryos or the exact number tested is not detailed.
- Stability Studies: Conducted to determine shelf life, testing pH, osmolality, endotoxin, HSA concentration, MEA, and sterility over time. The sample size (number of batches, number of samples per batch/time point) for these studies is not specified.
- Biocompatibility Testing: Performed for ORIGIO® Sequential Cleav™. This involves standardized in vitro and in vivo tests (cytotoxicity, sensitization, irritation). The sample size for these specific tests is not provided, but generally involves a predetermined number of test samples.
All data described appears to be retrospective (part of product development and qualification) and is generated by ORIGIO a/s (Denmark) or contracted laboratories.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. This product is an in vitro fertilization (IVF) medium, not a diagnostic device that requires expert ground truth for interpretation of discrete outputs. The "ground truth" for its performance is assessed through its physical and chemical properties and its ability to support embryo development (MEA), which are objective laboratory measurements, not subjective expert interpretations.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
N/A. As this is not a diagnostic device or a study involving human interpretation, an adjudication method for a "test set" is not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
N/A. No MRMC study was conducted. This device is an IVF medium, not an AI or imaging device involving human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
N/A. There is no algorithm or AI component to this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this product's performance is established by:
- Physicochemical standards: pH, osmolality, endotoxin levels are measured against predefined acceptable ranges.
- Biological performance standards: The Mouse Embryo Assay (MEA) serves as a biological ground truth, where successful development of mouse embryos (≥80% 1-cell MEA) indicates the medium's suitability.
- Comparison to predicate devices: The "ground truth" for substantial equivalence is met by demonstrating that the new devices have comparable technological characteristics and performance to legally marketed predicate devices.
8. The sample size for the training set
N/A. This is not a machine learning or AI device, so there is no training set in that context. The "training" in product development refers to formulation optimization and initial testing, but no specific "training set" of data is mentioned.
9. How the ground truth for the training set was established
N/A. See above.
{0}------------------------------------------------
a CooperSurgical Company
K133912 Page 1 of 5
K133912
MAY 1 4 2014
510(K) SUMMARY
Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination
| Submitted by: | ORIGIO a/sKnardrupvej 2,2760 Måløv,Denmark |
|---|---|
| Contact person: | Tove KjærDirector Corporate Regulatory AffairsORIGIO a/s |
| Phone: +45 4679 0220Fax: +45 4679 0300 | |
| Date Submitted: May 12, 2014 | |
| Device IdentificationTrade name: | ORIGIO® Sequential FertTMORIGIO® Sequential FertTM with phenol redORIGIO® Sequential CleavTMORIGIO® Sequential CleavTM with phenol red |
| Common name: | ORIGIO® Sequential FertTMORIGIO® Sequential CleavTM |
| Classification name: | Reproductive media and supplements (21 CFR 884.6180, ProductCode MQL) |
| Predicate devices:Cook Medical: | Cook IVF Fertilization Medium and Cook IVF Cleavage Medium(K002385). |
Description
ORIGIO® Sequential Fert™ is intended for in vitro fertilization of human oocytes.
Two versions of ORIGIO® Sequential Fert™ are available:
- Catalogue no. 8301: ORIGIO® Sequential Fert™ .
- Catalogue no. 8302: ORIGIO® Sequential Fert™ with phenol red .
ORIGIO® Sequential Cleav™ is intended for in vitro culture of human embryos until the 2-8 cell stage. The medium can also be used for transfer.
Two versions of ORIGIO® Sequential Cleav™ are available:
{1}------------------------------------------------
- Catalogue no. 8303: ORIGIO® Sequential Cleav™
- Catalogue no. 8304: ORIGIO® Sequential Cleav™ with phenol red
Both ORIGIO® Sequential Fert™ and ORIGIO® Sequential Cleav™ are aseptically filtered, non viscous solutions, light pink or colorless solutions, which are ready to use by professionals within assisted reproduction.
ORIGIO® Sequential Fert™ and ORIGIO® Sequential Cleav™ are contained in 10 mL or 60 mL transparent polyethylene terephthalate glycol (PETG) bottles with high density polyethylene (HDPE) closures, available in card board boxes of 1 x 10 mL and 1 x 60 mL bottles. The bottles and boxes are individually labeled. The boxes also contain instruction for use provided as package insert.
Indication for use
ORIGIO® Sequential Fert™ is for the fertilization of oocytes in vitro.
ORIGIO® Sequential Cleav™ is for the culture of embryos until the 2-8 cell stage. ORIGIO® Sequential Cleav™ can also be used for embryo transfer at day 2 or 3.
Technological characteristics
The design of ORIGIO® Sequential Fert™ and ORIGIO® Sequential Cleav™ as well as the predicates listed in this submission is based on each medium containing the appropriate nutrients for the embryo development stage it is intended for. Table 1 compares the technological characteristics of ORIGIO® Sequential Fert™ and ORIGIO® Sequential Cleav™ to the predicates Cook IVF Fertilization Medium and Cook IVF Cleavage Medium. Both similarities and differences are illustrated.
ORIGIO® Sequential Fert™ is for the fertilization of oocvtes in vitro. Cook IVF Fertilization Medium is intended for use during in vitro fertilization procedures for insemination and incubation of ocytes. The in vitro fertilization procedure includes insemination and incubation of the oocytes. Thus, the indication for use for ORIGIO® Sequential Fert™ is considered comparable to the predicate and the differences are not considered to represent a new intended use nor do they pose any safety or effectiveness issues.
ORIGIO® Sequential Cleav™ is for culture and transfer of embryos as the predicate Cook IVF Cleavage Medium. Thus, the intended use of ORIGIO® Sequential Cleav™ is considered identical to the predicate.
| Product | ORIGIO®Sequential Fert™ | Cook IVFFertilizationMedium | ORIGIO®Sequential Cleav™ | Cook IVF CleavageMedium |
|---|---|---|---|---|
| Indication for use | ORIGIO® SequentialFert™ is for thefertilization ofoocytes in vitro. | Cook IVFFertilization Mediumis intended for useduring in vitrofertilizationprocedures forinsemination andincubation ofoocytes. | ORIGIO® SequentialCleav™ is for theculture of embryosuntil the 2-8 cellstage.ORIGIO® SequentialCleav™ can also beused for embryotransfer at day 2 or3. | Cook IVF CleavageMedium is intendedfor use during invitro fertilizationprocedures forculture and transferof embryos. |
| Productspecification | ||||
| Product | ORIGIO®Sequential Fert™ | Cook IVFFertilizationMedium | ORIGIO®Sequential Cleav™ | Cook IVF CleavageMedium |
| pH | 7.3-7.5 | 7.5-7.8 (in air)7.3-7.5 (in 6% CO₂) | 7.2-7.4 | 7.5-7.8 (in air)7.3-7.5 (in 6% CO₂) |
| Osmolality(mOsm/kg) | 277-293 | 285-295 | 272-288 | 285-295 |
| Endotoxin (EU/mL) | <0.15 | <0.4 | <0.15 | <0.4 |
| Aseptically filtered | X | X | X | X |
| 1-cell MEA | ≥80% | ≥80% | ≥80% | ≥80% |
| Formulation | ||||
| Physiological salts | Sodium chloridePotassium chlorideSodium dihydrogenphosphateMagnesium sulphateCalcium chloride | X | Sodium chloridePotassium chlorideSodium dihydrogenphosphateMagnesium sulphate | X |
| Protein source | ||||
| HSA ProteinSupplementation | 5 mg/mL | X | 5 mg/mL | X |
| Drugs | ||||
| Gentamicinsulphate | 0.01 mg/mL | X | 0.01 mg/mL | X |
| Vitamins | ||||
| Calciumpantothenate | X | X | ||
| Folic acid | X | X | ||
| Amino acids | ||||
| Non essentialamino acids | X | X | X | X |
| Essential aminoacids | X | |||
| Energy substrates | ||||
| D-(+)-Glucose | X | X | X | |
| Calcium lactate | X | X | X | X |
| Sodium pyruvate | X | X | X | X |
| Buffering system | ||||
| Sodiumbicarbonate | X | X | X | X |
| Other | ||||
| Tri sodium citratedihydrate | X | X | ||
| Sodiumhyaluronate | X |
Table 1, Comparison of ORIGIO® Sequential Fert™ and ORIGIO® Sequential Fert™ with the predicates
{2}------------------------------------------------
The technological characteristics of ORIGIO® Sequential Fert™ and ORIGIO® Sequential Cleav™ are comparable to those of the predicate device. The main differences are:
- Vitamins: ORIGIO® Sequential Fert™ and ORIGIO® Sequential Cleav™ contain the . vitamins folic acid and calcium pantothenate in similar concentration ranges as added in other cleared ART media e.g. EmbryoAssist™ (K080473) and EmbryoGen® (K120136),
{3}------------------------------------------------
which both have fertilization of oocytes, culture of embryos until the 2-8 cell stage and embryo transfer as the indication for use. Thus, folic acid and calcium pantothenate have a history of use in other ART media and do not represent a new technology.
- Essential amino acids: ORIGIO® Sequential Cleav™ contains both essential and non . essential amino acids, whereas the predicate for this product. Cook IVF Cleavage Medium, only contains non essential amino acids. Essential amino acids are well known components of cleared ART media with indication for use for fertilization, culture of embryos until the 2-8 cell stage and embryo transfer e.g. ISM1™ (K030490) and SAGE 1-Step™ (K133707) and thus, do not represent a new technology.
- Glucose: ORIGIO® Sequential Fert™ contains glucose which is also present in the predicate Cook IVF Fertilization Medium. ORIGIO® Sequential Cleav™ contains a low level of glucose which is not present in the predicate but is found in a comparable concentration in other cleared ART media with the same indication for use. culture of embryos until the 2-8 cell stage and embryo transfer, e.q. EmbryoAssist™ (K080473). Thus, the addition of glucose has a history of use in cleavage stage culture media and does not represent a new technology.
- Citrate: ORIGIO® Sequential Fert™ and ORIGIO® Sequential Cleav™ contain citrate which is a well known component in ART media and has a history of use in media intended for fertilization, culture of embryos until the 2-8 cell stage and embryo transfer e.g. Universal IVF Medium (K991279) and EmbryoAssist™ (K080473). Thus, the addition of citrate does not represent a new technology.
- Sodium hyaluronate: ORIGIO® Sequential Cleav™ contains hyaluronate in a concentration . range similar to that added in other cleared ART media products e.g. SAGE 1-Step™ (K133707) which is indicated for use at the same developmental stage and for embryo transfer. Thus, the addition of sodium hyaluronate does not represent a new technology.
The differences in composition do not impact the substantial equivalence and do not raise any new types of safety or effectiveness concern.
Performance data
The product specifications for ORIGIO® Sequential Fert™ and ORIGIO® Sequential Cleav™ and the predicates are similar regarding sterility, pH, and Mouse Embryo Assay (MEA) test. The endotoxin level for ORIGIO® Sequential Fert™ and ORIGIO® Sequential Cleav™ is lower (<0.15 EU/mL) than for the predicates (<0.4 EU/mL) and thus do not raise any safety concerns.
Regarding the osmolality, the specification limit is a bit wider for ORIGIO® Sequential Fert™ and ORIGIO® Sequential Cleav™ (277-293 and 272-288 mOsm/kg, respectively) than for the predicates (285-295 mOsm/kq). However, the specification for ORIGIO® Sequential Fert™ is identical to the osmolality specification for Universal IVF Medium (K991279) which is also intended for fertilization of oocvtes, whereas the specification for ORIGIO® Sequential Cleav™ is the same as the one for EmbryoAssist™ (K080473) with the indication for use for culture of embryos until the 2-8 cell stage. Thus, the osmolality specifications for ORIGIO® Sequential Fert™ and ORIGIO® Sequential Cleav™ do not raise any safety concerns.
The shelf life of ORIGIO® Sequential Fert™ and ORIGIO® Sequential Cleav™ has been validated in stability studies to 36 weeks. The parameters which have been tested in the stability studies through shelf life includes pH, osmolality, endotoxin, HSA concentration, MEA, and sterility.
In general, ORIGIO® Sequential Fert™ and ORIGIO® Sequential Cleav™ are subject to the same control methods and, to a significant degree, contain the same components as the predicate devices. ORIGIO® Sequential Fert™ and ORIGIO® Sequential Cleav™ have similar handling procedures and storage conditions. Therefore, ORIGIO® Sequential Fert™ and ORIGIO®
{4}------------------------------------------------
Sequential Cleav™ are considered substantially equivalent to the predicate devices Cook IVF Fertilization Medium and Cook IVF Cleavage Medium (K002385).
Biocompatibility
ORIGIO® Sequential Fert™ will not come in contact with the body during use and therefore does not require biocompatibility testing to support its intended use.
ORIGIO® Sequential Cleav™ may be used for transferring embryos to the patient's uterus following culture. Biocompatibility testing per ISO 10993-1:2009 for a device with short duration contact with mucosal tissues (i.e., cytotoxicity, sensitization, and irritation) was conducted and . showed device materials to be biocompatible, supporting safety for use in embryo transfer procedures.
Conclusion
The conclusion from the performance and safety data, intended use comparison, product formulation comparison and test specification comparison, demonstrates that ORIGIO® Sequential Fert™ (with and without phenol red) and ORIGIO® Sequential Cleav™ (with and without phenol red) are suitable for their intended use, and meet the criteria in the comparison to the predicate devices (Cook IVF Fertilization Medium and Cook IVF Cleavage Medium, K002385) in which substantial equivalence has been demonstrated.
{5}------------------------------------------------
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 14, 2014
ORIGIO a/s Tove Kjaer Director Corporate Regulatory Affairs Knardrupvej2 Måløv 2760 Denmark
Re: K133912
Trade/Device Name: ORIGIO® Sequential Fert™ ORIGIO® Sequential Fert™ with phenol red ORIGIO® Sequential CleayTM ORIGIO® Sequential Cleav™ with phenol red Regulation Number: 21 CFR§ 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MQL Dated: April 8, 2014 Received: April 11, 2014
Dear Tove Kjacr,
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.
{6}------------------------------------------------
Page 2 - Tove Kjaer
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 (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,
Image /page/6/Picture/7 description: The image shows the text "Benjamin Asher-S". The text is written in a bold, sans-serif font. The letters "FDA" are stylized with a pattern of lines and shapes. The text is arranged horizontally, with "Benjamin" on the left, "FDA" in the middle, and "Asher-S" on the right.
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
{7}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K133912
Device Name
ORIGIO® Sequential Fert™ and ORIGIO® Sequential Feri™ with phenol red
Indications for Use (Describe)
ORIGIO® Sequential Fert™ is for the fertilization of oocytes in vitro.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
ーズ : 【 : 【 : 【 : 】 : 】 : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (9/13)
156 Productions Services (101) 443-6740
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
{8}------------------------------------------------
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."
FORM FDA 3881 (9/13)
{9}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K133912
Device Name
ORIGIO& Sequential Cleavi™ and ORIGIO® Sequential Cleav™ with phenol red
Indications for Use (Describe)
ORIGIO® Sequential Cleav™ is for the culture of embryos until the 2-8 cell stage. ORIGIOR Sequential Cleav™ can also be used for embryo transfer at day 2 or 3.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FOR FOR FOR USE ONLY 2 2 2 Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (9/13)
"SC" Mublisheng Scrivace (303) +43-6740
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
{10}------------------------------------------------
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."
§ 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.