HSA-SOLUTION, MODEL 10034/10064

• K Number: K021896
• Device Name: HSA-SOLUTION, MODEL 10034/10064
• Manufacturer: VITROLIFE SWEDEN AB
• Date Cleared: 2002-09-06 ( 88 days)
• Product Code: MQL
• Regulation Number: 884.6180

Intended Use

HSA-solution contains Human Serum Albumin solution (100 mg/mL) and is intended for use in assisted reproductive procedures which include gamete and embryo manipulation. These procedures include the use of HSA-solution as a supplement for culture medium. Not for use as an injectable product.

Device Description

Human Serum Albumin solution. For supplementation of gamete and embryo media.

Predicate Devices

K98354

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a Human Serum Albumin solution for use in assisted reproductive procedures and makes no mention of AI or ML technology.

Therapeutic

No

Explanation: The HSA-solution is described as a supplement for culture media in assisted reproductive procedures, particularly for gamete and embryo manipulation. It is not intended for direct application to the body to treat or prevent a disease or condition, which is characteristic of a therapeutic device.

Diagnostic

No
The device is a Human Serum Albumin solution intended for use as a supplement in assisted reproductive procedures (gamete and embryo manipulation), not for diagnosing a condition or disease.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "Human Serum Albumin solution," which is a physical substance, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is likely an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use explicitly states it's for "assisted reproductive procedures which include gamete and embryo manipulation." These procedures are performed in vitro (outside the body) and involve manipulating biological samples (gametes and embryos).
• Device Description: The description confirms it's a "Human Serum Albumin solution. For supplementation of gamete and embryo media." This further reinforces its use in an in vitro setting for manipulating biological materials.
• Not for injectable use: The statement "Not for use as an injectable product" clearly distinguishes it from a therapeutic product administered directly to a patient, which is a common characteristic of IVDs.
• Predicate Device: The mention of a predicate device, "Human Serum Albumin™ (510(k) # K98354)," which is likely also an IVD used in similar applications, strengthens the case for this device being an IVD.

While the document doesn't explicitly state "In Vitro Diagnostic," the intended use and device description strongly align with the definition of an IVD, which are reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. In this case, the "condition" is infertility, and the device is used in procedures to address it in vitro.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

HSA-solution contains Human Serum Albumin solution (100 mg/mL) and is intended for use in assisted reproductive procedures which includc gamete and embryo manipulation. These procedures include the use of HSA-solution as a supplement for culture medium. Not for use as an injectable product.

Product codes

MQL

Device Description

Human Serum Albumin solution. For supplementation of gamete and embryo media.

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)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Human Serum Albumin™ (510(k) # K98354)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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SEP 6 2002

IX. PREMARKET NOTIFICATION SUMMARY

| Submitted by: | Vitrolife Sweden AB
Mölndalsvägen 30
SE-412 63 Gothenburg
SWEDEN |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Eiler Anderson
Vitrolife Sweden AB
Mölndalsvägen 30
SE-412 63 Gothenburg
SWEDEN |
| Date Prepared: | June 7, 2002 |
| Trade Name: | HSA-solution™ |
| Common Name: | Assisted Reproduction Media |
| Classification Name: | Reproductive Media and Supplements
(21 C.F.R. § 884.6180) |
| Predicate Device: | Human Serum Albumin™ (510(k) # K98354) |
| Description of the Device: | Human Serum Albumin solution.
For supplementation of gamete and embryo
media. |
| Intended Use: | HSA-solution contains Human Serum Albumin
solution (100 mg/mL) and is intended for use in
assisted reproductive procedures which include
gamete and embryo manipulation. These
procedures include the use of HSA-solution as a
supplement for culture medium. Not for use as an
injectable product. |
| Technological Characteristics: | The technological characteristics of HSA-
solution™ are identical to other legally marketed
culture media classified under 21 C.F.R. §
884.6180, Reproductive Media and Supplements. |

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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.

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SEP 6 200

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 -

Vitrolife Sweden AB % Mr. Gary L. Yingling Kirkpatrick & Lockhart 1800 Massachusetts Avenue, NW WASHINGTON DC 20036-1800 Re: K021896

Trade/Device Name: HSA-solution™ Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: 85 MQL Dated: June 7, 2002 Received: June 10, 2002

Dear Mr. Yingling:

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.

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 Part 807); labeling (21 CFR Part 801); 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.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	[phone]
876.2xxx, 3xxx, 4xxx, 5xxx	[phone]
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	[phone]
892.2xxx, 3xxx, 4xxx, 5xxx	[phone]
Other	[phone]

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Henry C. Grigdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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X. - INDICATIONS FOR USE STATEMENT

510(k)_Number:

KO21896

Device Name:

HSA-solution™ Assisted Reproduction Media

Indications For Use:

HSA-solution contains Human Serum Albumin solution (100 mg/mL) and is intended for use in assisted reproductive procedures which includc gamete and embryo manipulation. These procedures include the use of HSA-solution as a supplement for culture medium. Not for use as an injectable product.

Rate Phillips ncs

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 5 10(k) Number _

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 C.F.R. § 801.109)

OR

Over-the Counter Use_