BIOPSY PIPETTES

K133257 · Research Instruments , Ltd. · MQH · May 16, 2014 · Obstetrics/Gynecology

Device Facts

• Record ID: K133257
• Device Name: BIOPSY PIPETTES
• Applicant: Research Instruments , Ltd.
• Product Code: MQH · Obstetrics/Gynecology
• Decision Date: May 16, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6130
• Device Class: Class 2

Indications for Use

Biopsy pipettes are used in assisted reproduction techniques (ART) for the removal of blastomere(s) from embryos or polar bodies from oocytes, which may be done in order to perform preimplantation genetic diagnosis (PGD) on the genetic materials in the biopsied cell(s).

Device Story

Biopsy pipettes are manual microtools used in assisted reproduction laboratories by embryologists. The device consists of a fine borosilicate glass tube with specific tip geometries (flat, non-spiked, or spiked) and varying inner diameters (14-40μm) and bend angles (0-45°). The operator uses the pipette to physically aspirate or remove blastomeres from embryos or polar bodies from oocytes. This procedure enables the collection of genetic material for preimplantation genetic diagnosis (PGD). The device is provided sterile and is intended for single-use. It functions as a mechanical tool; no electronic or automated processing is involved.

Clinical Evidence

Bench testing only. Performance validated via non-pyrogenic testing (LAL per AAMI ST72:2002/(R)2010, acceptance < 20 EU/device) and non-embryotoxicity testing (Mouse Embryo Assay, acceptance ≥80% blastocyst after 120h). Sterilization validated per ISO 11137-1:2006 and ISO 11137-2:2006. Packaging validated per ISO 11607-2:2006 and various ASTM standards (F1980-07, F1886-09, F2054-13, F1929-12).

Technological Characteristics

Borosilicate glass microtools; various tip profiles (flat, non-spiked, spiked) and diameters (14-40μm); bend angles 0-45°. Sterilized via gamma irradiation. Packaging validated per ISO 11607-2:2006 and ASTM F1980-07, F1886-09, F2054-13, F1929-12. Non-pyrogenic per AAMI ST72:2002/(R)2010.

Indications for Use

Indicated for use in assisted reproduction techniques (ART) for the removal of blastomere(s) from embryos or polar bodies from oocytes to facilitate preimplantation genetic diagnosis (PGD).

Regulatory Classification

Identification

Assisted reproduction microtools are pipettes or other devices used in the laboratory to denude, micromanipulate, hold, or transfer human gametes or embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods.

Special Controls

*Classification.* Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when the assisted reproduction microtools (pipettes) are manufactured from glass, 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

• RI Pipettes - ICSI Injection, Holding, Assisted Hatching, Denuding (K991261)
• Polar body biopsy micropipet and blastomere biopsy micropipet (K012811)

Submission Summary (Full Text)

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RESEARCH INSTRUMENTS LIMITED

Bickland Industrial Park, Faimouth, Cornwall, TR11 4TA, U.K. Tel: [phone] [[phone]] Fax: [phone] [[phone]] e-mail: [e-mail] www.research-instruments.com

#### 510(k) Summary

#### Date prepared

Wednesday, 07 May 2014

#### Submitter

| Company Name: | Research Instruments Ltd. |
|----------------------|--------------------------------|
| Registration Number: | 9617095 |
| Address: | Bickland Industrial Park |
| | Falmouth, |
| | Cornwall TR11 4TA |
| | United Kingdom |
| Telephone: | [phone] |
| Fax: | [phone] |
| Contact person: | David Lansdowne |
| Contact Title: | Technical Director |
| Contact email: | [e-mail] |

#### Device Name

Trade Name: RI Pipettes - Biopsy Common name: RI Pipettes Classification Name: Microtools, Assisted Reproduction (21CFR 884.6130, 85 MQH) Classification Panel: Obstetrics/Gynecology 510(K): K133257

## Predicate Device

The RI Pipette - Biopsy claim substantial equivalence to two devices which have US market clearance.

### Predicate 1

| Trade Name: | RI Pipettes - ICSI Injection, Holding, Assisted Hatching, Denuding |
|----------------------|--------------------------------------------------------------------|
| Manufacturer: | Research Instruments Ltd |
| Classification Name: | Microtools, Assisted Reproduction |
| 510(K): | K991261 |
| Regulation Number: | 21CFR 844.6130 |
| Product Code: | MQH |

#### Predicate 2

| Trade Name: | Polar body biopsy micropipet and blastomere biopsy micropipet |
|----------------------|---------------------------------------------------------------|
| Manufacturer: | Humagen Fertility Diagnostics, Inc |
| Classification Name: | Microtools, Assisted Reproduction |
| 510(K): | K012811 |
| Regulation Number: | 21CFR 884.6130 |
| Product Code: | MOH |

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# RESEARCH INSTRUMENTS LIMITED

#### Description of the Device

The Biopsy pipette is part of the RI Pipettes range. Other pipettes available in this range include ICSI Injection, ICSI Holding, and Assisted Hatching pipettes.

Biopsy pipettes are offered in a range

- ID sizes - 14μm, 20μm, 25μm, 30μm, 40μm .
- bend angles 0°, 15°, 20°, 25°, 30°, 35°, 40°, 45° .
- . tip profiles - flat , non-spiked (bevelled), spiked

All pipettes in this range are manufactured from very fine borosilicate glass, packed individually into a Twista-Pak (primary packaging) and sealed in a medical pouch. They are then batch sterilised by gamma irradiation.

#### Summary of Performance Testing

Each finished batch of pipettes is tested to prove

- . non-pyrogenic by Limulus Amoebocyte Lysate (LAL) per AAMI ST72:2002/(R)2010. Testing acceptance: < 20 EU/device
- . non-embryotoxic by Mouse Embryo Assay (MEA) Testing acceptance: Pass level: ≥80% blastocyst after 120h

The sterilization process was validated per ISO 11137-1:2006 and ISO 11137-2:2007.

The packaging was validated per ISO 11607-2:2006, ASTM F1980-07, ASTM F1886-09, ASTM F2054-13, and ASTM F1929-12.

Results of real-time aging studies demonstrate the device maintains its specifications for the duration of its shelf life.

#### Indications for Use

Biopsy pipettes are used in assisted reproduction techniques (ART) for the removal of blastomere(s) from embryos or polar bodies from oocytes, which may be done in order to perform preimplantation genetic diagnosis (PGD) on the genetic materials in the biopsied cells(s).

#### Technological Characteristics

RI Pipette - Biopsy claims substantial equivalence to the

- RI Pipettes range with respect to raw material, manufacturing process, packaging, sealing and 1. irradiation processes, pre-clinical testing and batch release criteria. The only difference between the RI Biopsy pipettes and the other pipettes in the RI range of pipettes is its intended use and tip geometry ie the size and profile of the tip is specific to the 'biopsy' intended use.
- 2. Humagen Pipettes with regard to raw material, manufacturing and irradiation processes and pre-clinical testing. The intended use is the same and tip geometry is also very similar. Any differences in geometry are the manufacturers' response to perceived user preference and do not affect the safety and effectiveness of the device when used as labelled. The RI Pipettes has a 3 year shelf life where the predicate device has a 2 year shelf life.

These differences do not affect the safety and effectiveness of the intended purpose.

#### Conclusion

The subject device is substantially equivalent to the predicate devices based on intended use, sterilization validation, and bench performance testing (MEA and LAL).

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.

#### Public Health Service

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

May 16, 2014

Research Instruments Limited David Lansdowne Technical Director Bickland Industrial Park Falmouth, Cornwall TR114TA United Kingdom

Re: K133257

> Trade/Device Name: RI Pipettes - Biopsy Regulation Number: 21 CFR§ 884.6130 Regulation Name: Assisted reproduction microtools Regulatory Class: II Product Code: MQH Dated: April 14, 2014 Received: April 14, 2014

Dear David 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.

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Page 2 - David Lansdowne

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/MedicalDeyices/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin Fisher -S

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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K133257

Device Name

RI Pipettes - Biopsy

#### Indications for Use (Describe)

Biopsy pipettes are used in assisted reproduction techniques (ART) for the removal of blastomere(s) from embryos or polar bodies from oocytes, which may be done in order to perform preimplantation genetic diagnosis (PGD) on the genetic materials in the biopsied cell(s).

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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