RI MSC (MIGRATION SEDIMENTATION CHAMBER) by RESEARCH INSTRUMENTS LTD.

The RI MSC is intended to prepare sperm by migration-sedimentation method for the assisted reproduction techniques of intracytoplasmic sperm injection (ICSI), in vitro fertilization (IVF) and intrauterine insemination (IUI).

Device Description

The Research Instruments Migration Sedimentation Chamber (RI MSC) is sterile, non-pyrogenic proven by Limulus Amebocyte Lysate and non-toxic to sperm proven by Human Sperm Survival Assay (HSSA). The RI MSC is disposable and labelled for single use, individually packaged in medical pouches and sold in boxes of twenty (x20) units. The RI MSC is manufactured from medical grade polystyrene and its surfaces are untreated. It is injection moulded as a completed unit, housing a central well with a surrounding gallery. The cylinder is 74 mm in height with a top OD of 16.5 mm and fluid capacity of 6 ml (approx) if completely filled; however, during recommended procedures it accommodates 1-2 ml of culture medium. The RI MSC facilitates the migration sedimentation technique. The migration sedimentation technique utilizes the innate 'swimming' ability of sperm to separate vigorous, A-motile sperm from non-motile or abnormal sperm and ejaculate debris.

AI/ML Overview

The provided 510(k) summary for the Research Instruments Migration Sedimentation Chamber (RI MSC) details non-clinical testing performed to demonstrate its substantial equivalence to a predicate device. It primarily focuses on material safety and performance for sperm compatibility.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Human Sperm Survival Assay (HSSA)	≥ 70% motility at 24 hours	≥ 70% motility at 24 hours
Endotoxins by Limulus Amebocyte Lysate (LAL)	< 0.5 Eu/device	< 0.5 Eu/device
Sterility Assurance Level (SAL)	10⁻⁶	10⁻⁶ (gamma irradiated)
Shelf Life	3 years	3 years (proven by packaging validations and biocompatibility testing of accelerated aged samples)
Non-pyrogenic	Proven	Proven by Limulus Amebocyte Lysate
Non-toxic to sperm	Proven	Proven by Human Sperm Survival Assay (HSSA)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not explicitly state the sample sizes used for the HSSA, LAL, or shelf-life testing. It only mentions "batch tested" for HSSA and LAL, implying that samples from manufacturing batches were used.
Data Provenance: The document does not specify the country of origin for the HSSA or LAL data. It describes the testing as "non-clinical testing" and does not indicate if it was retrospective or prospective in terms of data collection for specific human subjects. For the HSSA, human sperm is involved, but the document does not elaborate on ethical considerations or donor selection.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to the studies conducted. The document describes non-clinical testing (HSSA, LAL, sterility, shelf life) which relies on laboratory methods and established biological or chemical assays, not expert consensus or interpretation for "ground truth." The acceptance criteria for these tests are quantitative thresholds (e.g., motility percentage, endotoxin levels).

4. Adjudication Method for the Test Set

This is not applicable as the studies are laboratory-based and rely on direct measurements against pre-defined quantitative thresholds, not subjective expert adjudication.

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 is not applicable. The device is a physical labware item (Migration Sedimentation Chamber) for sperm preparation, not an AI or imaging diagnostic tool that would involve human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. The device is a physical product, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests is established by:

Validated laboratory assays:
- HSSA: Measures sperm motility against a predefined physiological threshold.
- LAL: Measures endotoxin levels against a predefined safety threshold.
- Sterility testing: Confirms absence of microbial growth to meet SAL.
- Shelf-life testing: Assesses material integrity and performance over time, often using accelerated aging methods correlated with real-time stability studies.

8. The Sample Size for the Training Set

This is not applicable. The device is a manufactured medical labware, not a machine learning model, so there is no training set in the AI sense.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the same reason as above.

Summary

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K112413

Bickland Industrial Park, Falmouth, Cornwall, TR11 4TA, UK Tel: 01326 372753 [+44 1326 372 753] Fax: 01326 378783 [+44 1326 378 783] quality@research-instruments.com www.research-instruments.com

510(k) Summary 21CFR807.92(c)

Date prepared 21CFR807.92(a)(1)

Monday, 25 June 2012

Submitter's information 21CFR807.92(a)(1)

Company Name:	Research Instruments Ltd.
Registration Number:	9617095
Address:	Bickland Industrial ParkFalmouth,Cornwall TR11 4TAUnited Kingdom
Telephone:	+44 (0) 1326 372 753
Fax:	+44 (0) 1326 378 783
Contact person:	David Lansdowne
Contact Title:	Technical Director
Contact email:	david@research-instruments.com

Device Names 21CFR807.92(a)(2)

Device Name:	Migration Sedimentation Chamber
Trade Name:	Research Instruments Migration Sedimentation Chamber (RI MSC)
Common name:	IVF Tissue Dish
Classification Name:	Labware, Assisted Reproduction (21CFR 884.6160, 85 MQK)
Classification Panel:	Obstetrics/Gynecology
510(k):	K112413

Predicate Device 21CFR807.92(a)(3)

The RI MSC claims substantial equivalence to

Trade Name:	IVF Center Well Dish
Common name:	IVF Tissue Culture Dish
Manufacturer:	Thermo Fisher Scientific(Nalge Nunc International)
Classification Name:	Labware, Assisted Reproduction (21CFR 884.6160, 85 MQK)
510(K):	K090429

JUL 13 2012

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Image /page/1/Picture/2 description: The image shows a logo with the letters 'RI' in a bold, stylized font. The letters are connected and have a flowing, almost cursive appearance. A curved line underlines the letters, adding a sense of elegance and movement to the design. The logo is simple, yet distinctive, making it easily recognizable.

Description of the device 21CFR807.92(a)(4)

The RI MSC is manufactured from medical grade polystyrene and its surfaces are untreated. It is injection moulded as a completed unit, housing a central well with a surrounding gallery. The cylinder is 74 mm in height with a top OD of 16.5 mm and fluid capacity of 6 ml (approx) if completely filled; however, during recommended procedures it accommodates 1-2 ml of culture medium.

The RI MSC facilitates the migration sedimentation technique. The migration sedimentation technique utilizes the innate 'swimming' ability of sperm to separate vigorous, A-motile sperm from non-motile or abnormal sperm and ejaculate debris.

2 hours prior to the moment of insemination by assisted reproduction techniques (ART), the chamber is pre-loaded with culture media into which unprepared (raw) sperm is pipetted. The semen is pipetted into the gallery only section of the chamber. During a short incubation period, motile sperm migrate to the over-laying medium and fall by gravity from the gallery into the central well cavity of the chamber. The resulting sample is ready for use in ART techniques.

The RI MSC design is based on existing technology described in the published literature paper 'Selection of human spermatozoa by migration sedimentation' by Mailloux-G', Lucena-C, Tea-N-T, Jondet-M. Contraception Fertilite Sexualite, 1990, Vol.18 No.117 Pg 1037-1039.

Indication for Use 21CFR807.92(a)(5)

Although the intended use of the predicate device differs from that of the RI MSC, both devices interact with the sample or gamete in exactly the same way, i.e. the devices are receptacles which are filled with culture media into which a sample is placed.

The essential difference between the devices is that where the IVF Center Well Dish only 'holds' the sample (gamete or embryo), the RI MSC 'holds' the sample (gamete/sperm) and 'allows it to be prepared' by it's own innate action, the interaction with the media contained within and the physical shape of the RI MSC which results in the collection of motile sperm in the central well.

These differences do not affect the safety and effectiveness of the device when used as labelled.

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K112413

Image /page/2/Picture/1 description: The image shows a logo with the letters 'RI' in a bold, sans-serif font. The letters are black and appear to be slightly stylized. A curved line is positioned beneath the letters, adding a design element to the logo. The overall impression is simple and modern.

Feature	RI MSC	IVF Center Well Dish
Indications for Use	Preparing sperm by migration-sedimentation method for theassisted reproduction techniques ofintracytoplasmic sperm injection(ICSI), in vitro fertilization (IVF), andintrauterine insemination (IUI).	Preparing and culturing gametes orembryos for use in human In VitroFertilization (IVF).
Contraindication	Not recommended for spermsamples with total motility rate <40%.	N/A
Target Population	Female ART patients	Female IVF patients
Design Features	Cylindrical container with internalgallery and well.Optically clear, with flat base.	Shallow circular container with 3 mlcenter reservoir,Optically clear, with flat baseSupplied with lid.
Patient/embryo contactmaterial	Polystyrene, non-treated	Polystyrene, non-treated
Sterility	Sterile (SAL 10-6) gamma irradiated	Sterile (SAL 10-6) gamma irradiated
Performance testingBio-compatibility	- Tested non-pyrogenic by LAL- Human Sperm survival Assay (HSSA)≥ 70% motility at 24hr	Tested non-pyrogenic by LALMouse Embryo Assay (MEA) 1-cellat ≥ 80% expanded blastocysts at 96hours

Technological Characteristics 21CFR807.92(a)(6)

The RI MSC and the predicate device IVF Center Well Dish, have similar applications which include the storage of gametes for Assisted Reproduction (AR) techniques. Both devices are sold sterile with SAL 10° and both are batch tested non-pyrogenic by LAL (Limulus Amebocyte Lysate). The containers are a single part, made of the same material polymer (Polystyrene) and are gamma irradiated.

The differences between the RI MSC and the IVF Center Well Dish (the predicate device) are

. the physical dimensions and shape of the containers i.e. the RI MSC is cylindrical with internal gallery and well. The IVF Center Well Dish is a shallow circular container with no internal configurations.
the IVF Center Well Dish is supplied with a lid, the RI MSC is not. .
The IVF Center Well Dish is intended to hold gametes and embryos during fertilization via . in vitro fertilization (IVF). The RI MSC is intended to hold and promote sperm migration and sedimentation in preparation for use in assisted reproduction techniques IVF, ICSI and IUI.
The predicate device tests for compatibility with the sample by MEA (Mouse Embryo . assay), whereas the RI MSC comes into contact with sperm only and is batch tested compatible by HSSA (Human Sperm Survival Assay).
. The RI MSC states a contraindication with regard to the type of sperm sample to be used while the predicate device does not state any contraindication. This is discussed in full in the Substantial Equivalency Discussion.

These differences do not affect the safety and effectiveness of the device.

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Non-clinical Testing [21CFR807.92(b)(1)]

The RI MSC non-clinical testing includes

sperm compatibility by HSSA to pass level: ≥ 70% motility at 24 hours .
endotoxins by LAL to a pass level: <0.5Eu/device .
sterility assurance to a level of 10° .
shelf life of 3 years, proven by packaging validations and biocompatibility testing of . accelerated aged samples.

Clinical Testing [21CFR807.92(b)(2)]

To our knowledge the RI MSC has not been involved in any clinical trials. The migration sedimentation technique was developed by Tea ' et al who used a glass tube with an inner cone to separate spermatozoa. The merits of this type of device and technique are discussed in a paper by Henkel and of this type of device are discussed in a paper by Lesage .

Tea-N-T, Jondet-M, Scholler-R (1984) A migration-gravity sedimentation method for collecting motile 1. spermatozoa from human semen. In Vitro Fertilization, Embryo Transfer and Early Pregnoncy. Pgs 117-120
Henkel-R-R, Schill-W-B, (2003) Sperm preparation for Art. Reproductive Biology and Enocrinology. 1/108 2.
Lesage-B, Vannin-A-5, Paramio-M-T, Emiliani-S, Debaisieux-L, Englert-Y, Leisnard-C (2006), Embryo 3. development and structural analysis of invitro matured bovine oocytes vitrified in flexipet denuding pipettes. Fertility and Sterility, Vol 86, No 1, Pas 121-128
Mailloux-G, Lucena-C, Tea-N-T, Jondet-M (1990), Selection of human spermatozoa by migration 4. sedimentation. Contraception Fertilite Sexualite, Vol.18 No.117 Pg 1037-1039.
ನ. Yener-C, Mathur-S, Parent-B, (1990), Comparison of Two sperm preparation techniques using Automated Sperm Motion Analysis : Migration sedimentation versus Swim-Up Archives of Andrology Vol 25, Pgs 17-20
1. Maya-W-D-C, Gutierrez-J-A-B, de la Rios-J-R, Jaramillo-A-P-C-J (2007), Functional Evaluation of Sperm in Colombian Fertile Men. Grupo Reproduccion Vol 60, No 7, Pgs 827-831
Hauser-R, Homonnai-Z-T, Poz-G-F, Yavetz-H, Amit-A, Lessing-J-B, Peyser-M-R, Yogev-L (1992) Migration 7. Sedimentation Technique as a predictive test for the fertilizing capacity of spermatozoa in an in vitro fertilization programme. International Journal of Andrology. Vol 15, No.6, Pgs 498-503
1. Schill-W-B, Kohn-F-M (1997) Therapy of Male subfertility. Zentrum fur Dermatologie und Andrologie. Vol147, No.4-5 Pgs 76-80 - see The Royal Society of Medicine literature search summaries no. 3

Conclusions [21CFR807.92 (b)(3)]

The RI MSC is substantially equivalent to the predicate device and performs as intended and described in the published medical literature.

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is presented in black and white, giving it a formal and official appearance.

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

Mr. David Lansdowne Technical Director Research Instruments Ltd. Bickland Industrial Park FALMOUTH CORNWALL TR11 4TA UNITED KINGDOM

JUL 13 2012

Re: K112413

Trade/Device Name: Research Instruments Migration Sedimentation Chamber (RI MSC) Regulation Number: 21 CFR§ 884.6160 Regulation Name: Assisted reproduction labware Regulatory Class: II Product Code: MQK Dated: June 25, 2012 Received: June 28, 2012

Dear Mr. Lansdowne:

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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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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.

Sincerély vours,

Sincerely yours,

Benjamin R. Evans

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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Bickland Industrial Park, Falmouth, Cornwall, TR11 4TA, UK Tel: 01326 372753 [International +44 1326 372 753] Fax: 01326 378783 [International +44 1326 378 783] quality@research-instruments.com www.research-instruments.com

Indications for Use

510(k) Number (if known): K112413

Device Name: Research Instruments Migration Sedimentation Chamber (RI MSC)

Indications for Use:

Prescription Use Yes (Part 21 CFR 801 Subpart D) AND/OR

No Over-The Counter Use_ (Part 21 CFR 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hala Lium

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K112413

Page

FDA RI MSC 510K-06-12

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Company Registered in England, Number: 341 9143

Registered Address: Bickland Industrial Park, Falmouth, Cornwall TR11 4TA VAT Number: 750 4247 49

Regulation Number and Section

§ 884.6160 Assisted reproduction labware.

(a)
Identification. Assisted reproduction labware consists of laboratory equipment or supplies intended to prepare, store, manipulate, or transfer human gametes or embryos for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures. These include syringes, IVF tissue culture dishes, IVF tissue culture plates, pipette tips, dishes, plates, and other vessels that come into physical contact with gametes, embryos or tissue culture media.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when it is a dish or plate intended for general assisted reproduction technology procedures, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.