COOPERSURGICAL MALLEABLE SYTLET

K023382 · Cooper Surgical · MQF · Dec 20, 2002 · Obstetrics/Gynecology

Device Facts

• Record ID: K023382
• Device Name: COOPERSURGICAL MALLEABLE SYTLET
• Applicant: Cooper Surgical
• Product Code: MQF · Obstetrics/Gynecology
• Decision Date: Dec 20, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6110
• Device Class: Class 2

Intended Use

The sterile singe-use devices are to be used in conjunction with an Edwards Catheter for in-vitro fertilization procedures where passage through the cervix is impeded.

Device Story

Single-use sterile malleable stylet; used with assisted reproduction catheters to facilitate cervical passage during in-vitro fertilization. Device consists of stainless steel inner rod encapsulated in Teflon (FEP) and detachable rigid outer sheath; connected via male/female Luer Lock. Outer sheath features 1cm distal graduations. Used in clinical settings by physicians; provides mechanical support to catheter to navigate impeded cervix. Benefits patient by enabling successful catheter placement for IVF procedures.

Clinical Evidence

Bench testing only. Biocompatibility testing per ISO 10993-1 and mechanical testing for ISO 594-1 (6% luer taper) compliance.

Technological Characteristics

Materials: Stainless steel inner rod, Teflon (FEP) encapsulation, Polypropylene Luers, Polyethylene tip protector. Dimensions: 18cm or 23cm length. Energy: None (mechanical). Sterilization: Sterile, single-use. Standards: ISO 10993-1 (biocompatibility), ISO 594-1 (conical fittings).

Indications for Use

Indicated for patients undergoing in-vitro fertilization procedures where passage through the cervix is impeded, requiring use of an assisted reproduction catheter.

Regulatory Classification

Identification

Assisted reproduction catheters are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to introduce or remove gametes, zygote(s), preembryo(s), and/or embryo(s) into or from the body. This generic type of device may include catheters, cannulae, introducers, dilators, sheaths, stylets, and component parts.

Special Controls

*Classification.* Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).

Predicate Devices

• Wallace Malleable Stylets (K990349)

Submission Summary (Full Text)

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DEC 2 0 2002

FDA 510(k) Premarket Notification CooperSurgical Malleable Stylet

KO23382

# 510 (k) Summary

Date Prepared [21 CFR 807.92(a)(1)]

October 7, 2002

# Submitter's Information [21 CFR 807.92(a)(1)]

Joseph M. Azary C/o CooperSurgical, Inc. P.O. Box 2156 Huntington, CT. 06484

Azary Technologies has received authorization to submit this 510(k) on behalf of the sponsor CooperSurgical, Inc., 95 Corporate Drive, Trumbull, CT 06611.

# Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]

Possible device trade names are: CooperSurgical Malleable Stylet or Edwards Malleable Stylet Common Name: Assisted Reproduction Catheters, Stylet

# Predicate Device [21 CFR 807.92(a)(3)]

Wallace Malleable Stylets - K990349

The subject devices have the same indications for use, material composition, sterilization method, and working dimensions as the predicate device. A minor difference lies in the luers of the subject device are slightly larger (both in diameter and length) than the predicate device. The subject device is packaged in a pouch composed of Tyvek and film, whereas the predicate device is packaged in a pouch composed of paper and film.

# Description of the Device [21 CFR 807.92(a)(4)]

Assisted Reproduction Catheters / Stylets are single-use sterile devices provided for use with CooperSurgical Assisted Reproduction Catheters, should passage through the cervix be impeded. The devices have an overall length of 23cm and 18cm and consist of a malleable inner stylet and a detachable rigid outer sheath, which is attached to the flexible inner stylet by a male/female Luer Lock adaptor. When the outer sheath Luer is attached to the hub of the stylet, the inner malleable stylet forms a smooth radius at the outer sheath. The outer sheath has a series of 1cm graduations at the distal end. The stainless steel stylet is encapsulated in Teflon (FEP).

The subject devices will be packaged in a flexible pouch composed of Tyvek heat sealed to polyethylene film. The pouch is designed to be peeled open. The pouches will be placed in a carton will contain 10 units.

The two versions are AR-ST18 (18cm length) and AR-ST23 (23cm length).

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| Component | Material | Details |
|---------------------|-------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Stylet Outer Sheath | Teflon | Fluortek FEP-20 White (aka<br>Neoflon NP-20) |
| Stylet Inner Rod | Stainless Steel | No patient contact. The 316<br>Stainless Steel is encapsulated in<br>Teflon (FEP). |
| Outer Sheath | Teflon | Fluortek FEP-20 White (aka<br>Neoflon NP-20) |
| Luers | Polypropylene (pink colorant<br>used in outer luer and blue color-<br>ant used in stylet luer). | Montell Profax 6323 Compounded<br>by Chroma with PMS 240 U Pink.<br><br>Montell Profax 6323 Compounded<br>by Chroma with PMS 300C Blue. |
| Tip Protector | Polyethylene | No patient contact |

The subject devices are composed of the following materials:

# Intended Use (21 CFR 807.92(a)(5)]

The sterile singe-use devices are to be used in conjunction with an Edwards Catheter for in-vitro fertilization procedures where passage through the cervix is impeded.

#### Technological Characteristics [21 CFR 807.92(a)(6)]

CooperSurgical, Inc. believes that the subject device is substantially equivalent to the predicate device. The subject device is composed of the same materials, sterilized using the same method, complies with the same standards, has the same indications for use, and has the same working dimensions. The minor differences are with the packaging and the outer diameter and length of the Luer.

#### Performance Data [21 CFR 807.92(b)(1)]

The subject device has been subject to biocompatibility testing (for the materials that is equivalent to ISO 10993-1 Biocompatibility requirements. The subject device also complies with ISO 594-1 1986 Conical fittings with a 6% (luer) taper requirements.

#### Conclusion [21 CFR 807.92(b)(3)]

We believe the changes are minor and conclude that the subject devices are as safe and effective as the predicate devices.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines extending from its head, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service .

nd Drug Administration 0 Corporate Boulevard ckville MD 20850

CooperSurgical, Inc. % Mr. Joseph M. Azary Azary Technologies, LLC P.O. Box 2156 HUNTINGTON CT 06484

### Re: K023382

Trade/Device Name: CooperSurgical, Inc. Malleable Stylet Regulation Number: 21 CFR 884.6110 Regulation Name: Assisted reproduction catheters Regulatory Class: II Product Code: 85 MQF Dated: December 3, 2002 Received: December 4, 2002

# Dear Mr. Azary:

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 (OS) 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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#### Page 2

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. Snogdon

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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FDA 510(k) Premarket Notification CooperSurgical Malleable Stylet

5.10(k) Number (if known): K023382

Device Name: CooperSurgical, Inc. Malleable Stylet

Indications For Use: The sterile singe-use devices are to be used in conjunction with CooperSurgical Assisted Reproduction Catheters for in-vitro fertilization procedures where passage through the cervix is impeded. : · : . :

(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 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

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(Division Sign-Off) Division of Reproductive, Al and Radiological Device 510(k) Number _

Page 4 510(k) Malleable Stylet