PNEUMOPERITONEUM INSUFFLATION NEEDLE

K021247 · Mectra Labs, Inc. · HIF · Nov 8, 2002 · Obstetrics/Gynecology

Device Facts

• Record ID: K021247
• Device Name: PNEUMOPERITONEUM INSUFFLATION NEEDLE
• Applicant: Mectra Labs, Inc.
• Product Code: HIF · Obstetrics/Gynecology
• Decision Date: Nov 8, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1730
• Device Class: Class 2

Intended Use

Pneumoperitoneum Insufflation Needle is intended for use during Endoscopic procedures, to establish a pneumoperitoneum prior to abdominal endoscopy.

Device Story

Pneumoperitoneum Insufflation Needle is a manual surgical instrument used by physicians during endoscopic procedures. The device is inserted into the abdominal cavity to facilitate the delivery of gas, establishing a pneumoperitoneum necessary for abdominal endoscopy. It functions as a conduit for insufflation. The device is used in clinical or surgical settings. By creating the required space within the abdomen, it allows for visualization and access during minimally invasive procedures, benefiting the patient by enabling endoscopic surgery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual surgical needle designed for insufflation. Materials and dimensions are consistent with standard laparoscopic insufflation needles. No energy source or software components.

Indications for Use

Indicated for use in patients undergoing abdominal endoscopic procedures requiring the establishment of a pneumoperitoneum.

Regulatory Classification

Identification

A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Charles E. Allgood Director, Administrative Support Division Mectra Labs, Inc. Two Quality Way P.O. Box 350 BLOOMFIELD IN 47424

Re: K021247

Trade/Device Name: Pneumoperitoneum Insufflation Needle Regulation Number: 21 CFR §884.1730 Regulation Name: Laparoscopic insufflator Regulatory Class: II Product Code: 85 HIF Dated: September 17, 2002 Received: September 17, 2002

Dear Mr. Allgood:

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 Clogdon

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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## 510(k) Number (if known)_KO21247

| Device Name: | Pneumoperitoneum Insufflation Needle |
|--------------|--------------------------------------|
|--------------|--------------------------------------|

Indications for Use:

Pneumoperitoneum Insufflation Needle is intended for use during Endoscopic procedures, to establish a pneumoperitoneum prior to abdominal endoscopy.

## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Uses (Per 21 CFR §801.109)

OR

Over The Counter Use

hind A. Sigmon

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