The Swemed Pipettes are intended to be used to denude, micromanipulate, hold or transfer human gametes or embryos for assisted hatching, ISCI, or other assisted reproduction methods.

The Swemed Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes are used for the intracytoplasmic single sperm injection of occytes; the Swemed Holding Pipettes are used to hold the occyte in position with the application of vacuum during single sperm injection with the micro-injection pipette; the Swemed Denuding Pipettes are used to remove the cumulus cell layers; and the Swemed Assisted Hatching/Zona Drilling Pipettes are used to make a hole in the zona pellucida to enable embryo assisted hatching.

Device Description

The Swemed Pipettes are manufactured by Swemed of borosilicate glass. The pipettes have inner diameters ranging from .0048 - . 190 mm and outer diameters ranging from . 0068 - . 280 mm. The pipette length ranges from 50 to 90 mm. The Denuding Pipette does not have a beveled tip. The ICSI, the holding, and the Assisted Hatching/Zona Drilling Pipettes have a 30-35° beveled tip. The pipettes are packaged in a rubber holder together with a glass tube. The tube is then provided in a seal made of aluminum foil. The pipette is dry heat sterilized by Swemed Lab International. The pipette is intended for single use only.

AI/ML Overview

The provided document is a 510(k) Summary for Swemed Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes, Holding Pipettes, Denuding Pipettes, and Assisted Hatching/Zona Drilling Pipettes.

Crucially, this document focuses on establishing substantial equivalence to a predicate device (Cook OB/GYN Pipettes) rather than presenting a performance study with defined acceptance criteria and detailed study results as would be found in a clinical trial report or a comprehensive validation study.

Therefore, most of the requested information regarding acceptance criteria, device performance metrics, sample sizes for test/training sets, expert qualifications, and adjudication methods is not available in the provided text. The document is primarily a regulatory submission demonstrating a lack of significant differences from a legally marketed device.

Here's a breakdown of what can be extracted and what is missing:

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

Acceptance Criteria	Reported Device Performance
Not explicitly defined in terms of quantitative performance metrics. The basis for substantial equivalence is "the same intended use" and "same indications for use" as the predicate device. Minor differences in dimensions and aspiration method are stated to "not affect the safety or effectiveness of the device."	The document states that the Swemed Pipettes "are very similar devices" to the Cook Pipettes, with minor differences in: 1. Dimensions: "inside and outside diameters, pipette lengths, and bevel angles are slightly different" 2. Aspiration Method for Denuding Pipettes: "Cook Denuding Pipettes can be ordered with a mouth aspiration tubing line, whereas the Swemed Denuding Pipettes are intended for use with a vacuum device."

Acceptance Criteria

Reported Device Performance

Not explicitly defined in terms of quantitative performance metrics. The basis for substantial equivalence is "the same intended use" and "same indications for use" as the predicate device. Minor differences in dimensions and aspiration method are stated to "not affect the safety or effectiveness of the device."

The document states that the Swemed Pipettes "are very similar devices" to the Cook Pipettes, with minor differences in: 1. Dimensions: "inside and outside diameters, pipette lengths, and bevel angles are slightly different" 2. Aspiration Method for Denuding Pipettes: "Cook Denuding Pipettes can be ordered with a mouth aspiration tubing line, whereas the Swemed Denuding Pipettes are intended for use with a vacuum device."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not applicable. No dedicated performance test set (as in a clinical study) is described. The comparison is based on device specifications and intended use against a predicate device.
Data Provenance: Not applicable. No clinical data or performance study data is presented to analyze.

3. 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)

Number of Experts: Not applicable. No "ground truth" establishment from experts is described for a performance study.
Qualifications of Experts: Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable. No performance study requiring adjudication is presented.

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

MRMC Study: No. This device is a micro-tool pipette, not an AI-assisted diagnostic tool. An MRMC study is not relevant to this type of device.
Effect Size of AI Improvement: Not applicable.

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

Standalone Performance: Not applicable. This is not an algorithm or an AI device.

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

Type of Ground Truth: Not applicable. The "ground truth" for this 510(k) submission is the existence and performance of the legally marketed predicate device (Cook Pipettes) and the manufacturer's assertion that the Swemed Pipettes perform equivalently for their intended use.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This is not an AI/machine learning device requiring a training set.

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

Ground Truth Establishment for Training Set: Not applicable.

Summary

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JUL-08-99 17:50 From:HDGAN & HARTSON 7W 109 1111111111111111

T-048 P.05/08 -Job-947

K991700

JUL 19 1999

—

Attachment 11

510(k) SUMMARY Swemed's Follicle Aspiration Set

Submitter's Name, Address, Telephone Number, Contact Person

Carl Gage Scan-Med, Inc. as U.S. distributor ------------------------------------------------------------------------------------------------------------------------------------------for Swemed Lab International AB Post Office Box 128 Middle Grove, New York 12850 OL Telephone: (800) 722-6016 Facsimile: (888) 722-6633

Edward C. Wilson, Jr., Esq. 555 Thirteenth Street, N.W. Washington, DC 20004-1109 Telephone: (202) 637-5839 Facsimile: (202) 637-5910

July 8, 1999 Date Prepared:

Name of Device and Name/Address of Sponsor

Swemed Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes, Holding Pipettes, Denuding Pipettes, and Assisted Hatching/Zona Drilling Pipettes

Scan-Med, Inc. as U.S. distributor for Swemed Lab International AB Post Office Box 128 Middle Grove. New York 12850 Telephone: (800) 722-6016 Facsimile: (888) 722-6633

Common or Usual Names

Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes, Holding Pipettes, Denuding Pipettes, and Assisted Hatching/Zona Drilling Pipettes

Classification Name

Assisted Reproduction Microtools

Predicate Devices

Cook OB/GYN Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes, Holding Pipettes, Denuding Pipettes, and Assisted Hatching/Zona Drilling Pipettes

Intended Use

The Swemed Pipettes are intended to be used to denude, micromanipulate, hold or transfer human gametes or embryos for assisted hatching, ISCI, or other assisted reproduction methods.

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Indications for Use

Technological Characteristics

Basis for Substantial Equivalence

The Swemed Pipettes have the same intended use as the predicate devices, the Cook Pipettes: to denude, micromanipulate, hold or transfer human gametes or embryos for assisted hatching, ICSI, or other assisted reproduction methods. The Swemed Pipettes also have the same indications for use as the predicate devices, the Cook Pipettes: the Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes are used for the intracytoplasmic single sperm injection of occytes; the Holding Pipettes are used to hold the oocyte in position with the application of vacuum during single sperm injection with the micro-injection pipette; the Denuding Pipettes are used to remove the cumulus cell layers; and the Assisted Hatching/Zona Drilling Pipettes are used to make a hole in the zona pellucida to enable embryo assisted hatching. Except for two minor features, the Swemed Pipettes and the Cook Pipettes are very similar devices. The primary differences between the Swemed Pipettes and the Cook Pipettes are that: (1) the inside and outside diameters, pipette lengths, and bevel angles are slightly different; and (2) the Cook Denuding Pipettes can be ordered with a mouth aspiration tubing line, whereas the Swemed Denuding Pipettes are intended for use with a vacuum device. These minor differences do not affect the safety or effectiveness of the device.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 19 1999

Swemed Lab International AB c/o Mr. Edward C. Wilson, Jr. Hogan & Hartson, L.L.P. 555 13th Street, N.W. Washington, D.C. 20004-1109 Re: K991700 Swemed Micropipettes Dated: May 18, 1999 Received: May 18, 1999 Requlatory Class: II 21 CFR §884.6130/Procode: 85 MQH

Dear Mr. Wilson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment 13

510(k) Number (if known): 991700

Device Name:

Swemed Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes; Swemed Holding Pipettes; Swemed Denuding Pipettes; and Swemed Assisted Hatching/Zona Drilling Pipettes

Indications for Use:

The Swemed Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes are used for the intracytoplasmic single sperm injection of oocytes, the Holding Pipettes are used to hold the oocyte in position with the application of vacuum during single sperm injection with the microinjection pipette, the Denuding Pipettes are used to remove the cumulus cell layers, and the Assisted Hatching/Zona Drilling Pipettes are used to make a hole in the zona pellucida to enable embryo assisted hatching.

(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)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number. K991700

Regulation Number and Section

§ 884.6130 Assisted reproduction microtools.

(a)
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.(b)
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.