The Pasteur Pipettes are radiation-sterilized, single use, transparent low-density polyethylene pipettes intended for handling and transferring of liquids, media and gametes during assisted reproductive technology (ART) procedures. The pipettes are provided in two sizes, 1 mL (Model 16201) and 3 mL (Model 16202). Each pipette includes an integrated bulb end that is used to aspirate and expel liquid, media and gamete to and from the device. The pipettes also include a molded volume scale along the body of the pipette. The volume scale only provides an estimate of the aspirated volume. The pipettes will not come in contact with the human body during use.

AI/ML Overview

The provided FDA 510(k) summary for the HertART Pasteur Pipette 3mL and 1mL describes the device, its intended use, comparison to a predicate device, and non-clinical performance data. However, the document does not contain information related to a study that proves the device meets specific acceptance criteria in the context of diagnostic accuracy, comparative effectiveness with human readers (MRMC), or standalone algorithm performance.

The document focuses on demonstrating substantial equivalence based on the device's physical properties, sterilization, packaging, and general biological safety (MEA and Endotoxin testing). It's a medical device clearance for a labware item, not an AI/ML or diagnostic device that would typically involve the type of performance studies you're asking about.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and reported device performance related to diagnostic accuracy.
Sample sizes for test sets, data provenance, number of experts for ground truth, or adjudication methods for a diagnostic study.
Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
Standalone (algorithm only) performance.
Ground truth types for diagnostic studies.
Training set sample size or ground truth establishment for a diagnostic algorithm.

The information extracted from the document pertains to the quality and safety of the physical pipettes as labware for assisted reproductive technology procedures.

Here is a summary of the non-clinical performance data and acceptance criteria as described in the document, which are focused on device quality and safety:

Acceptance Criteria and Reported Device Performance (Non-Clinical)

Test Category	Acceptance Criteria	Reported Device Performance
Sterile Validation	Sterilization Assurance Level (SAL) of 10^-6	Sterilization process and validation methods done in accordance with ISO 11137-1:2006 and ISO 11137-2:2013, achieving an SAL of 10^-6.
Package Validation	Sterile barrier maintained over two-year shelf-life	Testing demonstrated that the sterile barrier was maintained over the two-year shelf-life. Methods included ASTM F88/F88M-15, ASTM F3039-15, and ASTM F1886/F1886M-16.
Transport Testing	Ability to withstand rigors of shipping	Testing performed in accordance with ASTM D4169-16 to demonstrate the ability to withstand shipping rigors.
Stability and Shelf-life		Confirmed for a two-year shelf-life after accelerated aging per ASTM F1980-16.
-- Mouse Embryo Assay (MEA)	≥ 80% 1-cell expanded blastocyst within 96 hours	≤80% (This seems like a typo in the document where it states "≤80%" while the predicate says "≥ 80%". Assuming the "≥" is intended) 1-cell expanded blastocyst within 96 hours (tested after accelerated aging).
-- Endotoxin testing (LAL)	< 0.25 EU/device	< 0.25 EU/device (tested after accelerated aging).
-- Visual inspection	No scratches or discoloration	Conducted (after accelerated aging).
-- Liquid aspiration/maintenance	Liquid can be aspirated and maintained within the device	Testing to ensure liquid can be aspirated and maintained within the device (after accelerated aging).
-- Volume marker validation	(Implicit: Volume scale provides estimate)	Validation testing conducted (after accelerated aging).

Regarding the specific questions you asked:

A table of acceptance criteria and the reported device performance: See the table above. These are quality and safety performance criteria.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a physical labware device's non-clinical testing. The "test set" would refer to sample pipettes used in the described physical and biological tests. No specific numbers are provided for these samples in this summary beyond the general statement of "testing conducted."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. "Ground truth" in this context would be laboratory standards for sterility, endotoxin levels, and physical integrity, not a consensus interpretation by medical experts.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This device is not an AI/ML diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): For the biological and physical tests, the "ground truth" is defined by established international standards (ISO, ASTM, USP) for sterility, material properties, and biological safety.
The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
How the ground truth for the training set was established: Not applicable.

This document clearly outlines the non-clinical testing for a physical medical device (Pasteur Pipette) to demonstrate its performance and safety for its intended use as assisted reproduction labware. The requests about AI/ML performance, diagnostic accuracy, and expert involvement for ground truth are not relevant to this specific device and the information provided in the 510(k) summary.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 16, 2020

HertART ApS Ann-Catherine Ericson RA Manager Gustaf Werners gata 2 Västra Frölunda, SE-421 32 Sweden

K201213 Re:

Trade/Device Name: Pasteur Pipette 3mL, Pasteur Pipette 1mL Regulation Number: 21 CFR§ 884.6160 Regulation Name: Assisted Reproduction Labware Regulatory Class: II Product Code: MQK Dated: November 2, 2020 Received: November 18, 2020

Dear Ann-Catherine Ericson:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201213

Device Name Pasteur Pipette 3mL, Pasteur Pipette 1 mL

Indications for Use (Describe)

The Pasteur Pipettes are intended for handling and transferring of liquids, media and gametes during assisted reproductive technology procedures.

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows the word "HertART" in blue and red font. The word "Hert" is in blue, and the word "ART" is in red. To the right of the word "HertART" is the phrase "at the beginning of life" in blue font. The text is on a white background.

510(k) Summary - K201213

Date prepared: December 7, 2020

Applicant:	HertART ApSGustaf Werners gata 2SE-421 32 Västra FrölundaSwedenPhone: +46 (0) 708 22 80 28Email: psvensson@vitrolife.comFax: +46 (0) 31 721 80 90
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Contact Person: Ann-Catherine Ericson RA Manager Phone: +46 (0) 701 64 88 36 Email: aericson@vitrolife.com

Device Information 1

Trade Name: Pasteur Pipette 3mL, Pasteur Pipette 1mL Common name: Pasteur Pipettes Regulation number: 21 CFR 884.6160 Regulation name: Assisted Reproduction Labware Product code: MQK (Labware, Assisted Reproduction) Class: II

1.1 Predicate Device:

K000915 - Pasteur Pipet - Sterile 9, Pasteur Pipet - Sterile 5 3/4, Models 16-PP-9, 16-PP-5.75, Humagen Fertility Diagnostics, Inc.

The predicate has not been subject to a pipette design-related recall.

2 Device description

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Image /page/4/Picture/1 description: The image shows the logo for HertART. The word "Hert" is in blue, and the word "ART" is in red. The words "at the beginning of life" are in blue and are located to the right of the word "ART". The logo has a reflection underneath it.

2.1 Indications for Use

The Pasteur Pipettes are intended for handling and transferring of liquids, media and gametes during assisted reproductive technology procedures.

Comparison of Subject and Predicate Device Intended Use and 3 Technological Characteristics

Attribute	Subject DevicePasteur PipetteK201213	Predicate DevicePasteur PipetK000915	Differences
Indicationsfor Use	The Pasteur Pipettesare intended forhandling andtransferring of liquids,media and gametesduring assistedreproductivetechnology procedures.	Pasteur pipets are ageneral laboratorypipette to be usedanytime there is a needto move fluid or cells.They may also be usedto "denuda" ova prior toan ivf procedure.	The indications for the subject andpredicate devices are not identical. Boththe predicate and subject devices areindicated for handling of gametes, media,and other fluids; however, the predicate isalso indicated for use in denuding oocytes.This difference only represents a morelimited use of the subject devices ascompared to the predicate and does notimpact the overall intended use of thedevices (handling and transferring fluids,media, and gametes used in assistedreproduction procedures), which are thesame.
Design	Single piece moldedPasteur pipette	Glass Pasteur pipette tobe used with separatebulb	Different: There are differences in thedesigns of the subject and predicatedevices; however, they do not raisedifferent questions of safety andeffectiveness (S&E).
Material	Low densitypolyethylene	Borosilicate glass	Different: The subject and predicate devicematerials are not the same. Differences inmaterials do not raise different questions ofS&E.
Size	15.2 cm	5.75" (14.6cm) and 9"(22.9cm)	Different: Both the 1 mL and 3 mL subjectdevices have the same length, which isdifferent than the predicate that is providedin two lengths. Differences in length do notraise different questions of S&E.
Volumecapacity	1 mL and 3 mL	Unknown	Different: The volume capacity of thepredicate is not known; however,differences in volume capacity do not raisedifferent questions of S&E.
Packaging	Peel open pouchconsisting of PE/PA-film and a BOPET /Adhesive / EZ Peel®Sealant500 pouches of onepipette each packed ina cardboard box	Material of pouches notknown.30 pouches of threepipettes each packed inboxes of 90 (30pouches)	Different: Packaging is different for thesubject device as compared to the predicatedevice. Differences in packaging do notraise different questions of S&E.
Sterile	Yes - Gammairradiation	Yes -Dry heat	Different: Different sterilization methodsare used for the subject and predicatedevices. Differences in sterilizationmethods do not raise different questions ofS&E.
Shelf-life	2 years	Unknown	Different: The shelf-life of the predicate isnot known; however, differences in shelf-life do not raise different questions of S&E.
Endotoxintesting(LAL)	≤ 0.25 EU/device	LAL tested, limits notspecified	Different: Endotoxin testing wasconducted on the predicate device;however, the acceptance specification is notknown. Differences in endotoxin testing donot raise different questions of S&E.
MouseEmbryoAssay(MEA)	≥ 80% 1-cell expandedblastocyst within 96hours	MEA tested, limits notspecified	Different: MEA testing was conducted onthe predicate device; however, theacceptance specification is not known.Differences in MEA testing do not raisedifferent questions of S&E.

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Image /page/5/Picture/1 description: The image shows the word "HertART" in blue and red font, followed by the phrase "at the beginning of life" in blue font. The word "Hert" is in blue, while "ART" is in red. The phrase "at the beginning of life" is smaller in size compared to the word "HertART". The text is horizontally aligned and appears to be a logo or title.

As stated in the table, the subject and predicate devices have similar indications for use statements and have the same intended use (i.e., handling and transferring fluids, media, and gametes used in assisted reproduction procedures).

The subject and predicate devices have differences in technological characteristics, including their design, materials, packaging, etc. As stated in the table, the differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness.

Non-clinical Performance Data 4

4.1 Sterile validation

The subject devices are gamma irradiation sterilized. The sterilization process and validation methods were done in accordance with ISO 11137-1:2006 and ISO 11137-2:2013. The sterilization assurance level of the subject devices is 10-6.

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Image /page/6/Picture/1 description: The image shows the logo for HertART. The word "Hert" is in blue, and the letters "ART" are in red. The tagline "at the beginning of life" is in blue and is located to the right of the red "ART".

4.2 Package Validation

Verification of the ability of device packaging to maintain a sterile barrier over the two-year shelf-life of the device was assessed using the following methods:

Seal strength testing according to ASTM F88/F88M-15 "Standard Test Method for Seal ● Strength of Flexible Barrier Materials"
. Dye penetration test according to ASTM F3039-15 "Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration"
. Visual inspection according to ASTM F1886/F1886M-16 "Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection"

Testing demonstrated that the sterile barrier was maintained over the two-year shelf-life.

4.3 Transport Testing

Simulated transport testing was conducted to demonstrate the ability of device packaging to withstand the rigors of shipping. Testing was performed in accordance with ASTM D4169-16.

4.4 Stability and Shelf life

The proposed shelf-life of the subject device is two years. The following tests were conducted on newly manufactured devices and devices after accelerated aging in accordance with ASTM F1980-16:

Mouse Embryo Assay (MEA (1-cell, expanded blastocyst within 96 hours) ≤80%)
Endotoxin testing per USP<85> (<0.25 EU/device) ●
Visual inspection (no scratches or discolorization)
Testing to ensure liquid can be aspirated and maintained within the device ●
. Volume marker validation testing

5 Conclusions

The results of the testing described above demonstrate that the Pasteur Pipette 1mL and Pasteur Pipette 3mL are as safe and effective as the predicate and supports a determination of substantial equivalence.

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.