ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash
Device Facts
| Record ID | K153267 |
|---|---|
| Device Name | ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash |
| Applicant | Origio A/S |
| Product Code | MQL · Obstetrics/Gynecology |
| Decision Date | Jul 22, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.6180 |
| Device Class | Class 2 |
Indications for Use
ORIGIO® Sperm Wash is intended for washing of spermatozoa, the isolation of motile viable sperm by swim-up method, dilution of ORIGIO gradients, and holding sperm for IUI procedure. ORIGIO® Gradient™ 100, ORIGIO® Gradient™ 90 and ORIGIO® Gradient™ 40/80 are for separation of motile sperm from the ejaculate by the density gradient method.
Device Story
ORIGIO® Sperm Wash and Gradient™ devices are reproductive media used in clinical laboratories for sperm preparation. Sperm Wash is a non-viscous solution used for washing, swim-up isolation, and IUI holding. Gradient™ devices (100, 90, 40/80) are viscous solutions containing silane silica to create density layers for separating motile sperm from ejaculate via centrifugation. Clinicians use these media to process semen samples; the resulting motile sperm are then used for fertility procedures. The devices are provided as sterile, aseptically filtered solutions in PETG bottles. By isolating high-quality, motile sperm, the devices assist in optimizing samples for clinical ART/IUI, potentially improving fertilization outcomes.
Clinical Evidence
Bench testing only. Testing included pH, osmolality, density, Human Sperm Survival Test (≥80% of control), endotoxin levels (≤0.15-0.8 EU/ml), and sterility (SAL 10^-3). Biocompatibility testing (cytotoxicity, sensitization, irritation) per ISO 10993-1:2009 confirmed safety for IUI use. Shelf-life and stability studies were conducted. Effectiveness of sperm separation was evaluated by comparing motility, morphology, viability, purity, and integrity against predicate devices, demonstrating comparable performance.
Technological Characteristics
Aseptically filtered, colorless solutions. Gradient™ devices contain silane silica for density; Sperm Wash is non-viscous. Ingredients include HSA, NaCl, bicarbonate, citrate, and taurine. PETG bottles with HDPE closures. Sterilization via aseptic filtration (EN/ISO 13408-2:2011). Shelf-life: 20-36 weeks unopened, 4 weeks opened.
Indications for Use
Indicated for use in assisted reproductive technology (ART) procedures for the separation of motile, viable sperm from ejaculate via density gradient or swim-up methods, and for holding sperm for intrauterine insemination (IUI).
Regulatory Classification
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.).
Special Controls
*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.
Predicate Devices
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 22, 2016
ORIGIO a/s Tove Kjaer Director Corporate Requlatory Affairs Knardrupvej 2 2760 Måløv Denmark
Re: K153267
> Trade/Device Name: ORIGIO® Sperm Wash, ORIGIO® Gradient™ 100, ORIGIO® Gradient™ 90 and ORIGIO® Gradient™ 40/80 Regulation Number: 21 CFR& 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MQL Dated: June 21, 2016 Received: June 23, 2016
Dear Tove Kjaer,
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.
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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 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.
# Joyce M. Whang -S
for
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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#### 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
ORIGIO® Sperm Wash, ORIGIO® Gradient™ 100, ORIGIO® Gradient™ 90 and ORIGIO® Gradient™ 40/80
#### Indications for Use (Describe)
ORIGIO® Sperm Wash is intended for washing of spermatozoa, the isolation of motile viable sperm by swim-up method, dilution of ORIGIO gradients, and holding sperm for IUI procedure
ORIGIO® Gradient™ 100, ORIGIO® Gradient™ 90 and ORIGIO® Gradient™ 40/80 are for separation of motile sperm from the ejaculate by the density gradient method.
| <span></span> | <span></span> ☒ Prescription Use (Part 21 CFR 801 Subpart D) |
|---------------|--------------------------------------------------------------|
| <span></span> | <span></span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Type of Use (Select one or both, as applicable)
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# 510(k) SUMMARY
| 510(k) Number: | K153267 |
|-----------------|----------------------------------------------------------------------------------------------------------------|
| Submitted by: | ORIGIO a/s<br>Knardrupvej 2<br>2760 Måløv<br>Denmark |
| Contact person: | Tove Kjær<br>Director Corporate Regulatory Affairs<br>ORIGIO a/s<br>Phone: +45 4679 0220<br>Fax: +45 4679 0300 |
Date Prepared: July 21, 2016
#### Device Identification:
| Trade name: | ORIGIO® GradientTM 100 (Cat. No. 8400)<br>ORIGIO® GradientTM 90 (Cat, No. 8401)<br>ORIGIO® GradientTM 40/80 (Cat, No. 8402)<br>ORIGIO® Sperm Wash (Cat, No. 8405) |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common name: | Density Gradient and Sperm Wash |
| Classification name: | Reproductive media and supplements (21 CFR 884.6180, Product<br>Code MQL) |
### Predicate Devices:
SupraSperm™ System (K003404) from ORIGIO is the predicate device for ORIGIO® Gradient™ devices
Sperm Preparation Medium (K991332) from ORIGIO is the predicate device for ORIGIO® Sperm Wash.
### Device Description:
ORIGIO® Sperm Wash and ORIGIO® Gradient™ devices are for separation of motile sperm from semen and handling of sperm. These devices are based on the same formulation, but differ in the content of Human Serum Albumin (HSA), NaCl, bicarbonate, and silane silica. The silane silica generates the density, thus it is an ingredient in the ORIGIO® Gradient™ devices only and is not present in ORIGIO® Sperm Wash. All subject devices, except ORIGIO® Gradient™ 100, contain gentamicin and HSA.
The subject devices are aseptically filtered, colorless solutions. ORIGIO® Gradient™ devices are viscous while ORIGIO® Sperm Wash is non-viscous. They are contained in transparent polyethylene terephthalate glycol (PETG) bottles with high density polyethylene (HDPE) closures, available in card board boxes, individually labeled and with instruction for use provided as a package insert. The subject devices are quality control tested for the following specifications:
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| Criteria | ORIGIO® Sperm<br>Wash | ORIGIO® Gradient™ | | | |
|---------------------------|-----------------------|-------------------|-------------|-------------|-------------|
| | | 40 | 80 | 90 | 100 |
| pH | 7.95-8.495 | | | | |
| Osmolality (mOsm/kg) | 272-288 | 317-333 | 297-313 | | |
| Density (g/ml) | N/A | 1.048-1.062 | 1.098-1.112 | 1.105-1.119 | 1.123-1.137 |
| Human Sperm Survival Test | ≥80% of control | | | | |
| Endotoxin (EU/ml) | ≤0.15 | ≤0.8 | | | |
| Sterility | No growth (SAL10-3) | | | | |
| HSA concentration (mg/ml) | 10 | 5 | 5 | 5 | N/A |
#### Indications for Use:
ORIGIO®Sperm Wash is intended for washing of spermatozoa, the isolation of motile viable sperm by swim-up method, dilution of ORIGIO® gradients, and holding sperm for IUI procedure.
ORIGIO®Gradient™ 100, ORIGIO® Gradient™ 90 and ORIGIO® Gradient™ 40/80 are for the separation of motile sperm from the ejaculate by the density gradient method.
#### Performance and Safety Data:
#### Product Specifications
The bench testing demonstrated that the subject devices met all product specifications.
#### Biocompatibility
Since ORIGIO® Sperm Wash can also be used for IUI (Intrauterine insemination), it mav have direct contact with the uterus (patient). In accordance with ISO 10993-1:2009, the cytotoxicity, sensitization and irritation tests have been conducted on this device and the results demonstrate that ORIGIO® Sperm Wash is safe.
#### Sterilization Validation
The subject devices are manufactured by aseptically filtration that was validated in accordance with EN/ISO 13408-2:2011. These products have a sterility assurance level (SAL) of 10-3.
#### Shelf-Life
The shelf-life study covering all product specifications has been conducted on the subject devices. The results demonstrate that Gradient™ 100 has a 20-week shelf-life whereas the other subject devices have a 36-week shelf-life in unopened bottle under recommended storage conditions. In addition, all subject devices are stable for four weeks under recommended storage conditions after the bottles have been opened.
#### Effectiveness of Separation of Motile Sperm
The sperm separated using subject devices were evaluated for motility, morphology. viability, purity and integrity in comparison with predicate and other cleared devices. The results demonstrate that the subject and predicate devices have comparable performance.
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## Predicate Device Comparison:
## ORIGIO® Sperm Wash
ORIGIO® Sperm Wash and its predicate device have the same intended use. The subject device is different from predicate devices in pH; however, this difference is commonly seen in reproductive media. Regarding formulation, there are following differences between the subject and predicate devices:
- . Citrate is present in ORIGIO® Sperm Wash at higher concentration compared to the predicate device. However, citrate is a natural component in semen and present in much higher concentration than in ORIGIO® Sperm Wash.
- . Sodium bicarbonate is present in ORIGIO® Sperm Wash at lower concentration compared to the predicate device, but within the range of other cleared sperm wash media.
- . Unlike the predicate device, Synthetic Serum Replacement (SSR) is not present in ORIGIO® Sperm Wash. However, SSR is also absent in other cleared media intended for sperm handling. Therefore, absence of SSR is not considered detrimental for the sperm cells.
- . HSA concentration has been increased from 5 mg/ml in the predicate device to 10 mg/ml in ORIGIO® Sperm Wash. However, the level of HSA in ORIGIO® Sperm Wash is still much lower than physiological level.
- Taurine is present in ORIGIO® Sperm Wash but absent in the predicate device. ● However, taurine which is widely used in ART media, including cleared devices with similar indication.
Taken together, the differences do not raise new types of questions. Performance data shows that ORIGIO® Sperm Wash is as safe and effective as the predicate device. Therefore, ORIGIO® Sperm Wash is substantially equivalent to the predicate device in terms of safety and effectiveness.
### ORIGIO® Gradient™ devices
ORIGIO® Gradient™ devices and their predicate device have the same intended use. Gradient™ devices are different from the predicate device in pH and osmolality; however, these differences are commonly seen in reproductive media. Regarding formulation, there are following differences between the subject and predicate devices:
- ORIGIO® Gradient™ 40 contains a slightly higher concentration of NaCl, as ● compared to the predicate device, in order to adjust the medium to a slightly higher osmolality. However, the NaCl concentration used is still within the physiological range of semen.
- Taurine is present in ORIGIO® Gradient™ devices but absent in the predicate . device. However, taurine is widely used in ART media, including cleared devices with similar indication.
- HSA concentration has been increased to 5 mg/ml in ORIGIO® Gradient™ 40, 80 ● and 90. This concentration is within the normal range of cleared media intended for sperm.
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- Citrate is present in ORIGIO® Gradient™ devices at higher concentration . compared to the predicate device. However, citrate is a natural component in semen and present in much higher concentration than in ORIGIO® Gradient™ devices.
- . ORIGIO® Gradient™ devices do not contain SSR or phenol red compared to the predicate device. However, absence of SSR and phenol red are commonly seen in cleared media intended for sperm and therefore, it is not considered detrimental for the sperm cells.
Taken together, the differences do not raise new types of questions. Performance data shows that ORIGIO® Gradient™ devices are as safe and effective as the predicate device. Therefore, ORIGIO® Gradient™ devices are substantially equivalent to the predicate device in terms of safety and effectiveness.
