H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TRAY & MULTIPURPOSE PROCEDURE TRAY

K020954 · Ackrad Laboratories · LKF · Apr 24, 2002 · Obstetrics/Gynecology

Device Facts

• Record ID: K020954
• Device Name: H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TRAY & MULTIPURPOSE PROCEDURE TRAY
• Applicant: Ackrad Laboratories
• Product Code: LKF · Obstetrics/Gynecology
• Decision Date: Apr 24, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.4530
• Device Class: Class 2

Indications for Use

Procedure trays containing components intended for the delivery of diagnostic contrast media agents in the female reproductive tract for examination of the uterus and fallopian tubes (i.e. Hysterosalpingography or Hysterosonography).

Device Story

The H/S Procedure Tray, H/S Elliptosphere Procedure Tray, and Multi-Purpose Procedure Tray are sterile, single-use kits containing medical components for hysterosalpingography (x-ray) or hysterosonography (ultrasound). These trays are used by clinicians to facilitate the delivery of diagnostic contrast media into the female reproductive tract. The device provides the necessary tools for the examination of the uterus and fallopian tubes. The output is the successful administration of contrast media to enable imaging, which assists the physician in diagnosing reproductive tract conditions. The device is intended for clinical use.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Sterile, single-use procedure trays containing various medical components. Materials, design, and sterilization processes are identical to the predicate device. No electronic, software, or energy-based components.

Indications for Use

Indicated for patients undergoing diagnostic examination of the uterus and fallopian tubes via hysterosalpingography or hysterosonography requiring delivery of contrast media agents.

Regulatory Classification

Identification

An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:(1) An amniotome is an instrument used to rupture the fetal membranes. (2) A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant. (3) An umbilical clamp is an instrument used to compress the umbilical cord. (4) A uterine curette is an instrument used to scrape and remove material from the uterus. (5) A fixed-size cervical dilator is any of a series of bougies of various sizes used to dilate the cervical os by stretching the cervix. (6) A uterine elevator is an instrument inserted into the uterus used to lift and manipulate the uterus. (7) A gynecological surgical forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynecological examination. (8) A cervical cone knife is a cutting instrument used to excise and remove tissue from the cervix. (9) A gynecological cerclage needle is a looplike instrument used to suture the cervix. (10) A hook-type contraceptive intrauterine device (IUD) remover is an instrument used to remove an IUD from the uterus. (11) A gynecological fibroid screw is an instrument used to hold onto a fibroid. (12) A uterine sound is an instrument used to determine the depth of the uterus by inserting it into the uterine cavity. (13) A cytological cervical spatula is a blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina. (14) A gynecological biopsy forceps is an instrument with two blades and handles used for gynecological biopsy procedures. (15) A uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus. (16) An internal pelvimeter is an instrument used within the vagina to measure the diameter and capacity of the pelvis. (17) A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina. (18) A fiberoptic nonmetal vaginal speculum is a nonmetal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.

Special Controls

*Classification.* (1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.(2) Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.

Predicate Devices

• Ackrad H/S Procedure Tray (K881680)

Submission Summary (Full Text)

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K020954

# Attachment 4

## 510(k) Summary

| Device Description | Trade Names: H/S Catheter Procedure Tray H/S Elliptosphere Procedure Tray Multipurpose Procedure Tray |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Common Name: Hysterosalpingography or Hysterosonography Trays (Product Code LKF) |
| | Classification Name: Unclassified |
| Predicate Device | Ackrad H/S Procedure Tray K881680, 7/15/88 |
| Date | April 23, 2002 |
| Contact | Richard Hettenbach Vice President, Regulatory Affairs and Quality Assurance Ackrad Laboratories, Inc. 70 Jackson Drive Cranford, NJ 07016 Tel: [phone] Fax: [phone] |
| Device Description | The H/S Procedure Tray, Elliptosphere Procedure Tray and Multi-Purpose Tray contain components that can be used for conducting either Hysterosalpinography (examination of the uterus and fallopian tubes using x-rays) or Hysterosonography (examination of the uterus and falopian tubes using ultrasound sonography). All components are provided sterile for single use only. |

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| Technological<br>Characteristics | The expanded tray has the same technological characteristics as the<br>predicate device. The intended use, operating principle, incorporate the<br>same product designs incorporate the same materials and are packaged and<br>sterilized using the same materials and processes. |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion | The H/S Catheter Procedure Tray, H/S Elliptosphere Procedure Tray and<br>Multi-Purpose Procedure Tray are substantially equivalent to the predicate<br>H/S Procedure Tray. |

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a human figure.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### APR 2 4 2002

Mr. Richard Hettenbach Vice President, Regulatory Affairs and Quality Assurance Ackrad Laboratories 70 Jackson Drive CRANFORD NJ 07016

Re: K020954

Trade Name: H/S Procedure Tray (5F and 7F), Model 61-5205 and 61-5207 H/S Elliptosphere procedure Tray, Model 61-4205 Multi-purpose Procedure Tray, Model 61-2000 Regulation Number: None Regulatory Class: Unclassified

Product Code: 85 LKF Dated: March 13, 2002

Received: March 25, 2002

Dear Mr. Hettenbach:

We have reviewed your Section 510(k) premarket notification of intent to market the device w f no re revealed above and have determined the device is substantially equivalent to legally marketed relected devices marketed in interstate commerce prior to May 28, 1976, the enactment date of produced at nevice Amendments or to devices that have been reclassified in accordance with the urovisions of the Federal Food, Drug, and Cosmetic Act (the Act). You may, therefore, market provision, subject to the general controls provisions of Act. However, you are responsible to determine that the medical devices you use as components in the tray have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. 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.

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#### Page 2 - Mr. Hettenbach

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 or any I vith 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 Orth 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.

In addition, we have determined that your device kit contains providone-iodine ointment and providone-iodine solution which are subject to regulation as drugs.

Our substantially equivalent determination does not apply to the drug components of your our ourse. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug components. For information on applicable Agency requirements for marketing these drugs, we suggest you contact:

Director, Division of Drug Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 [phone]

This letter will allow you to begin marketing your device as described in your Section 510(k) rms leter natification. The FDA finding of substantial equivalence of your device to a legally premated 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 Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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### Attachment 2

# Indications for Use Statement 510(k) K020954 Number H/S Procedure Tray Device Name H/S Elliptosphere Procedure Tray Multipurpose Procedure Tray Procedure trays containing components intended for the delivery of Indications for diagnostic contrast media agents in the female reproductive tract for Use examination of the uterus and fallopian tubes (i.e. Hysterosalpingography or Hysterosonography).

#### PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED

#### Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C Brandon

livision Sign-Off) / Division of Reproductive, Abd ominal, and Radiological Device 12095 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The Counter Use__________________________________________________________________________________________________________________________________________________________