ORIGIO® Sequential Blast™ is for the culture of embryos from the 4-8 cell stage through to the blastocyst stage. ORIGIO® Sequential Blast™ can also be used for embryo transfer.

Device Description

ORIGIO® Sequential Blast™ (with and without phenol red) is intended for the culture of human embryos from the 4-8 cell stage through to the blastocyst stage and for embryo transfer.

Two versions of ORIGIO® Sequential Blast™ are available:

Catalogue no. 8305: ORIGIO® Sequential Blast™ .
. Catalogue no. 8306: ORIGIO® Sequential Blast™ with phenol red

Both versions of ORIGIO® Sequential Blast™ are aseptically filtered, non viscous solutions, light pink or colorless solutions, which are ready to use by professionals within assisted reproduction.

The ORIGIO® Sequential Blast™ media 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.

AI/ML Overview

The provided document is a 510(k) summary for ORIGIO® Sequential Blast™ and ORIGIO® Sequential Blast™ with phenol red, a reproductive media for culturing human embryos. It focuses on demonstrating substantial equivalence to a predicate device, BlastAssist® (K080172), rather than presenting a study to prove acceptance criteria for a device involving AI or human-in-the-loop performance. Therefore, many of the requested elements are not applicable to this type of submission.

However, I can extract the relevant information regarding acceptance criteria and performance data for this specific medical device (embryo culture media):

1. A table of acceptance criteria and the reported device performance

The document provides a comparison of product specifications between the proposed device (ORIGIO® Sequential Blast™) and the predicate device (BlastAssist®), which serve as the de-facto acceptance criteria for demonstrating substantial equivalence. The reported device performance is indicated by its ability to meet these comparable specifications.

Product Specification	Proposed Device (ORIGIO® Sequential Blast™)	Predicate Device (BlastAssist®)
pH	7.2-7.5	7.3-7.5
Osmolality (mOsm/kg)	272-288	272-288
Endotoxin (EU/mL)	<0.15	≤0.1
Sterility	No growth	No growth
1-cell MEA	≥80%	≥80%

2. Sample size used for the test set and the data provenance

The document describes "stability studies" and "Mouse Embryo Assay (MEA) test" as part of the performance data. However, it does not explicitly state the sample size for these tests or the data provenance (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as the device is an embryo culture medium, not an AI or diagnostic device requiring expert interpretation of results for ground truth establishment.

4. Adjudication method for the test set

This information is not applicable for the same reason as point 3.

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

This information is not applicable as the device is not an AI or diagnostic device that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable as the device is not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this type of device, the "ground truth" or validation is based on:

Physicochemical properties: Meeting specified pH, osmolality, and endotoxin limits.
Sterility: Absence of microbial growth.
Biological performance: Mouse Embryo Assay (MEA) demonstrating proper embryonic development (≥80% 1-cell MEA).
Stability studies: Showing the product maintains its specifications over its shelf life.

8. The sample size for the training set

This information is not applicable as the device is not an AI or machine learning system that requires a "training set."

9. How the ground truth for the training set was established

This information is not applicable for the same reason as point 8.

Summary

{0}------------------------------------------------

a CooperSurgical Company

K133387

APR 2 9 2014

510(K) SUMMARY

Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination

Submitted by:	ORIGIO a/sKnardrupvej 22760 MåløvDenmarkTel: +45 46790200Fax: +45 46790300
Contact person:	Tove KjærDirector Corporate Regulatory AffairsORIGIO a/s
	Date Submitted: April 11, 2014
Device IdentificationTrade Name:	ORIGIO® Sequential Blast™ORIGIO® Sequential Blast™ with phenol red
Common name:	ORIGIO® Sequential Blast™
Classification Name:	Reproductive media and supplements (21 CFR 884.6180, ProductCode MQL)
Predicate DeviceORIGIO a/s	BlastAssist® (K080172)

Description

ORIGIO® Sequential Blast™ (with and without phenol red) is intended for the culture of human embryos from the 4-8 cell stage through to the blastocyst stage and for embryo transfer.

Two versions of ORIGIO® Sequential Blast™ are available:

Catalogue no. 8305: ORIGIO® Sequential Blast™ .
. Catalogue no. 8306: ORIGIO® Sequential Blast™ with phenol red

Both versions of ORIGIO® Sequential Blast™ are aseptically filtered, non viscous solutions, light pink or colorless solutions, which are ready to use by professionals within assisted reproduction.

{1}------------------------------------------------

Indication for use

ORIGIO® Sequential Blast™ is for the culture of embryos from the 4-8 cell stage through to the blastocyst stage.

ORIGIO® Sequential Blast™ can also be used for embryo transfer.

Technological Characteristics

The design of ORIGIO® Sequential Blast™ as well as the predicate 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 Blast™ to the predicate BlastAssist®. Both similarities and differences are illustrated.

ORIGIO® Sequential Blast™ is for culture and transfer of embryos as the predicate BlastAssist". Thus, the intended use of ORIGIO® Sequential Blast™ is considered identical to the predicate.

Product	ORIGIO® Sequential Blast™	BlastAssist®
Indication for use	ORIGIO® Sequential Blast™ is for theculture of embryos from the 4-8 cellstage through to the blastocyst stage.ORIGIO® Sequential Blast™ can alsobe used for embryo transfer.	BlastAssist® is for culture from the 4-8 cellstage through to blastocyst stage. Can alsobe used for embryo transfer.
Productspecification
pH	7.2-7.5	7.3-7.5
Osmolality(mOsm/kg)	272-288	272-288
Endotoxin (EU/mL)	<0.15	≤0.1
Sterility	• No growth	No growth
1-cell MEA	≥80%	≥80%
Formulation
Physiological salts	Magnesium sulphatePotassium sulphateSodium chlorideSodium dihydrogen phosphate	Magnesium sulphatePotassium sulphateSodium chlorideSodium dihydrogen phosphate
Amino acids	X	X
Stable form of L-glutamine	N-Alanyl-L-glutamine	N-Acetyl-L-glutamine
Energy sources	GlucoseCalcium-L-lactateSodium pyruvate	GlucoseCalcium-L-lactateSodium pyruvate
SSR®	X	X
Buffer	Sodium Bicarbonate	Sodium Bicarbonate

Table 1. Comparison of ORIGIO® Sequential Blast™ with the predicate.

{2}------------------------------------------------

Product	ORIGIO® Sequential Blast™	BlastAssist®
Vitamins	X	X
Sodiumhyaluronate	X
Protein source
HSA (Proteincomposition: > 96%albumin)	5 mg/mL	2 mg/mL
Antibiotics
Gentamicinsulphate	10 µg/mL	10 µg/mL

The technological characteristics of ORIGIO® Sequential Blast™ are comparable to those of the predicate device. The main differences are:

Human Serum Albumin: The majority of commercially available culture media have an HSA . concentration of 5 mg/mL e.g. Universal IVF Medium (K K991279) and G-2™v5 (K081117).
Sodium hyaluronate: ORIGIO® Sequential Blast™ contains hyaluronate in a concentration . range similar to that added in other ART media products e.g. G-2™v5 (K081117).
Stable L-glutamine: Both ORIGIO® Sequential Cleav™ and the predicate contain a stable � form of glutamine. Both alanyl-glutamine used in ORIGIO® Sequential Blast™ and acetylglutamine used in the predicate are widely used in ART media and have a history of safe use.

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 Blast™ and the predicate are similar regarding sterility, osmolality, pH, endotoxin level and Mouse Embryo Assay (MEA) test.

The shelf life of ORIGIO® Sequential Blast™ 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 Blast™ is subject to the same control methods and, to a significant degree, contains the same components as the predicate device. ORIGIO® Sequential Blast™ has similar handling procedures and storage conditions. Therefore, ORIGIO® Sequential Blast™ is considered substantially equivalent to the predicate device BlastAssist® (K080172).

Biocompatibility

ORIGIO® Sequential Blast™ is categorized as a medium in direct contact with embryos from the 4-8 cell stage through to the blastocyst stage. Since ORIGIO® Sequential Blast™ can also be used for embryo transfer, it is also in direct contact with the uterus (patient). The biological safety evaluation (ISO 10993-1) demonstrates that ORIGIO® Sequential Blast™ consists of well tested components and is non-toxic in use. ORIGIO® Sequential Blast™ is therefore considered safe for culture of human embryos as well as transfer of embryos into the patient (uterus).

{3}------------------------------------------------

Conclusion

The conclusion from the performance and safety data, intended use comparison, product formulation comparison and test specification comparison, demonstrates that ORIGIO® Sequential Blast™ (with and without phenol red) is suitable for the intended use, and meets the criteria in the comparison to the predicate device (BlastAssist®, K080172) in which substantial equivalence has been demonstrated.

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three wavy lines representing the serpents. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 29. 2014

ORIGIO als Tove Kjaer Director Corporate Regulatory Affairs Knardrupvej 2 Måløv 2760 Denmark

Re: K133387

Trade/Device Name: ORIGIO® Sequential Blast™ and ORIGIO® Sequential Blast™ with phenol red Regulation Number: 21 CFR§ 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MOL Dated: March 14, 2014 Received: March 31, 2014

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 practive, 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.

{5}------------------------------------------------

Page 2 - Tove Kjaer

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Image /page/5/Picture/7 description: The image shows the name "Herbert P. Lerner -S" in a bold, sans-serif font. The letters are black against a white background, making them easily readable. The text appears to be a title or heading, possibly indicating a person's name or a business name.

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

{6}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K133387

Device Name

ORIGIO® Sequential Blast™ and ORIGIO® Sequential Blast™ with phenol red

Indications for Use (Describe)

ORIGIO® Sequential Blast™ is for the culture of embryos from the 4-8 cell stage through to the blastocyst stage. ORIGIO® Sequential Blast™ can also be used for embryo transfer.

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.

THE ONLY CONTRACT PERSON FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Herbert P. Ler 2014.04.29

Regulation Number and Section

§ 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.