SF SH CATHETER, MODEL R65-945

K013437 · A & A Medical, Inc. · LKF · Nov 19, 2001 · Obstetrics/Gynecology

Device Facts

• Record ID: K013437
• Device Name: SF SH CATHETER, MODEL R65-945
• Applicant: A & A Medical, Inc.
• Product Code: LKF · Obstetrics/Gynecology
• Decision Date: Nov 19, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4530
• Device Class: Class 2

Intended Use

THE SONOHYSTEROGRAPHY CATHETER (5 Fr) IS INDICATED FOR USE TO FILL THE UTERUS WITH STERILE SALINE TO FACILITATE THE ULTRASOUND EXAMINATION OF THE UTERUS

Device Story

5F SH Catheter is a manual medical device used by physicians in clinical settings to facilitate sonohysterography. The device consists of a 5 French, 32 cm single-lumen catheter with a distal side port and a female luer-lock hub, paired with a semi-rigid introducing sheath (17.5 cm). The sheath features a flanged, rounded distal end to minimize tissue trauma during insertion. The catheter is banded with non-toxic ink for depth visualization. In operation, the physician inserts the device to deliver sterile saline into the uterine cavity. This saline distension improves the visualization of the uterine cavity during ultrasound imaging, aiding the physician in diagnostic assessment. The device is intended for prescription use.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on descriptive comparison of technological characteristics, materials, and intended use.

Technological Characteristics

5 French diameter, 32 cm length single-lumen catheter; semi-rigid introducing sheath (17.5 cm). Materials are biocompatible. Sterilization via Ethylene Oxide. Manual operation; no energy source, software, or electrical components.

Indications for Use

Indicated for use in patients undergoing ultrasound examination of the uterus, requiring uterine filling with sterile saline.

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

• Ultra Catheter Set for Sonohysterography (K001115)

Submission Summary (Full Text)

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## NOV 1 9 2001

# KOI 3437 510(k) Summary As Required by 21 section 807.92 ( c )

- 1-Submitter Name: A & A Medical, Inc.
- 9370 Industrial Trace 2-Address:
- Alpharetta, GA 30004
- (770) 343- 8400 3-Phone:
- (770) 343- 8985 4-Fax:
- Jay Mansour 5-Contact Person:
- 6-Date summary prepared: October 8tt, 2001

7-Device Trade or Proprietary Name: 5F SH Catheter

8-Device Common or usual name: Catheter for Sonohysterography

Cannula, Manipulator/Injector, Uterine 9-Device Classification Name:

10-Substantial Equivalency is claimed against the following device:

- Ultra Catheter Set for Sonohysterography, from Lyco Enterprises, Inc. ●
- 11-Description of the Device:

The device is to be used by physicians in hospitals

The 5F SH catheter consists of two parts: a single lumen catheter and a semi-rigid introducing sheath.

The catheter is available in a 5 French diameter with a length of 32 cm. The distal end has a side port. The proximal end is fitted with a female luer-lock hub. The catheter is banded with a non-toxic ink 7 cm from the distal tip

The semi-rigid sheath has an internal diameter to allow movement over the catheter and a wall thickness sufficient to provide semi-rigid flexibility. The sheath is 17.5 cm long and flanged and rounded at the distal end to provide a non-traumatic surface to the tissues. The proximal end allows for temporary fixation over the proximal hub of the catheter.

#### 12-Intended use of the device:

The SF SH Catheter is a device used to fill the uterus with sterile saline to facilitate the ultrasound examination of the uterus

#### 13-Safety and Effectiveness of the device:

This device is safe and effective as the other predicate device cited above. This is better expressed in the tabulated comparison (Paragraph 14 below)

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### 14-Summary comparing technological characteristics with other predicate device:

Please find below a tabulated comparison supporting that this device is substantially equivalent to other medical devices in commercial distribution. Also, Equivalency overview chart path is attached.

| FDA file reference number | 510k K001115 |
|-----------------------------------------------------|------------------------------------------------|
| Attachments inside notification<br>submission file | REFER TO TABLE ON PAGE 11 OF 12 FOR<br>DETAILS |
| TECHNOLOGICAL<br>CHARACTERISTICS | Comparison result |
| Indications for use | Identical |
| Target population | Identical |
| Design | Identical |
| Materials | Identical |
| Performance | Identical |
| Sterility | Similar (Ethylene Oxide instead of Gamma) |
| Biocompatibility | Identical |
| Mechanical safety | Identical |
| Chemical safety | Identical |
| Anatomical sites | Identical |
| Human factors | Identical |
| Energy used and/or delivered | Identical |
| Compatibility with environment<br>and other devices | Identical |
| Where used | Identical |
| Standards met | Identical |
| Electrical safety | Identical (not applicable) |
| Thermal safety | Identical (not applicable) |
| Radiation safety | Identical (not applicable) |

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#### 510(k) "SUBSTANTIAL EQUIVALENCE" DECISION-MAKING PROCESS (DETAILED)

Image /page/2/Figure/1 description: This image is a flowchart that outlines the process for determining whether a new device is substantially equivalent to a marketed device. The flowchart starts with comparing the new device to a marketed device and proceeds through a series of questions about the device's intended use, technological characteristics, and potential impact on safety and effectiveness. The flowchart uses a series of yes/no questions to guide the user through the process, ultimately leading to a determination of whether the new device is substantially equivalent or not.

- 510(k) submissions compare new devices to marketed devices. FDA requests additional information in the relationship cen marketed and "predicate" (pe-Amendments or reclassified post-Amendments) devices is unclear. be
· This decision is normally based on descriptive information alone, but limited testing information is somelines required.

*** Data may be in the 310(k), other S10(k)s, the Center's classification files, or the literature.

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Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized symbol that resembles three wavy lines or a caduceus without the staff.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 9 2001

Jay Mansour, MSQA, BE, LA, RAC Ouality and Regulatory Manager A&A Medical, Inc. 9370 Industrial Trace ALPHARETTA GA 30004

Re: K013437

Trade/Device Name: Sonohysterography Catheter, Model R65-946 Regulation Number: None Regulatory Class: Unclassified Product Code: 85 LKF Dated: October 8, 2001 Received: October 17, 2001

Dear Mr. Mansour:

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 (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.

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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,

Nancy 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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NOV 1 9 2001
Page 1 of 1

| 510(k) Number (if known): | K013437 |
|---------------------------|---------------------------------------------|
| Device Name: | SONOHYSTEROGRAPHY CATHETER (5 Fr) [R65-946] |
| Indications For Use: | |

THE SONOHYSTEROGRAPHY CATHETER (5 Fr) IS
INDICATED FOR USE TO FILL THE UTERUS WITH
STERILE SALINE TO FACILITATE THE ULTRASOUND
EXAMINATION OF THE UTERUS(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

.

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | Nancy Bralon |
|---------------------------------------------------------------|--------------|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K013437 |

| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use (Optional Format 1-2-96) |
|---------------------------------------|----|-----------------------------------------------|
|---------------------------------------|----|-----------------------------------------------|

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