K Number
K073452
Device Name
MODIFICATION TO: ARAGON SURGICAL LAPCAP
Date Cleared
2008-01-11

(32 days)

Product Code
Regulation Number
884.1730
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Aragon Surgical LapCap is intended for use in the peri-umbilical region of the abdominal wall with a Veress needle for the establishment of a pneumoperitoneum during gynecologic (pelvic) and general surgical (intraabdominal) laparoscopic procedures.
Device Description
The Aragon Surgical LapCap is a single-use device used during laparoscopic surgical procedures. The device consists of a bell-shaped polycarbonate dome housing containing a pass-through port for introduction of a standard Veress needle and a vacuum port for attachment to a standard hospital vacuum line.
More Information

Not Found

No
The device description and intended use describe a purely mechanical device for establishing pneumoperitoneum. There is no mention of AI, ML, image processing, or data analysis.

No.
The device is used to establish pneumoperitoneum for laparoscopic procedures, which is a preparatory step for surgery rather than a treatment for a disease or condition.

No
The device description states its function is to establish a pneumoperitoneum during laparoscopic procedures, which is a procedural step, not a diagnostic one.

No

The device description clearly states it is a "single-use device" consisting of a "bell-shaped polycarbonate dome housing containing a pass-through port" and a "vacuum port". These are physical components, indicating it is a hardware device, not software-only.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
  • Device Function: The Aragon Surgical LapCap is a surgical accessory used during a laparoscopic procedure to help establish a pneumoperitoneum (inflating the abdomen with gas). It is a mechanical device that interacts with the body externally and internally during surgery, but it does not analyze biological samples to provide diagnostic information.
  • Intended Use: The intended use clearly states it's for "establishment of a pneumoperitoneum during gynecologic (pelvic) and general surgical (intraabdominal) laparoscopic procedures." This is a surgical function, not a diagnostic one.

The device description and intended use clearly indicate it's a surgical tool, not a diagnostic test performed on biological samples.

N/A

Intended Use / Indications for Use

The Aragon Surgical LapCap is intended for use in the peri-umbilical region of the abdominal wall with a Veress needle for the establishment of a pneumoperitoneum during gynecologic (pelvic) and general surgical (intraabdominal) laparoscopic procedures.

Product codes

HIF

Device Description

The Aragon Surgical LapCap is a single-use device used during laparoscopic surgical procedures. The device consists of a bell-shaped polycarbonate dome housing containing a pass-through port for introduction of a standard Veress needle and a vacuum port for attachment to a standard hospital vacuum line.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

peri-umbilical region of the abdominal wall

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Aragon Surgical LapCap (K070651)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)

Not Found

§ 884.1730 Laparoscopic insufflator.

(a)
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.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter kits which include accessory instruments that are not used to effect intra-abdominal insufflation (pneumoperitoneum). 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.

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5. 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Date Prepared: December 7, 2007

510(k) number: _______________________________________________________________________________________________________________________________________________________________

JAN 1 | 2008

Applicant Information:

Aragon Surgical, Inc. 1810 Embarcadero Road, Suite B Palo Alto, CA 94304

Device Information:

Trade Name:Aragon Surgical LapCap
Classification:Class II21CFR 884.1730
Product Code:HIF
Classification Name:Laparoscopic Insufflator and Accessories

Physical Description:

The Aragon Surgical LapCap is a single-use device used during laparoscopic surgical procedures. The device consists of a bell-shaped polycarbonate dome housing containing a pass-through port for introduction of a standard Veress needle and a vacuum port for attachment to a standard hospital vacuum line.

Intended Use:

The Aragon Surgical LapCap is intended for use in the peri-umbilical region of the abdominal wall with a Veress needle for the establishment of a pneumoperitoneum during gynecologic (pelvic) and general surgical (intraabdominal) laparoscopic procedures.

Equivalent Device:

The subject device is substantially equivalent in intended use/technological characteristics and/or method of operation to the Aragon Surgical LapCap (K070651).

Summary:

Based on the intended use and technological characteristics information provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure with outstretched arms.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 1 2008

Mr. Alan Curtis Vice President Regulatory/Clinical/Quality Affairs Aragon Surgical 1810 Embarcadero Road, Suite B PALO ALTO CA 94303

Re: K073452

Trade/Device Name: Aragon Surgical LapCap Regulation Number: 21 CFR 884.1730 Regulation Name: Laparoscopic insufflator Regulatory Class: II Product Code: HIF Dated: December 7, 2007 Received: December 14, 2007

Dear Mr. Curtis:

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 such 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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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.

This letter will allow you to begin marketing your device as described in your Section 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxxx(Gastroenterology/Renal/Urology)240-276-0115
21 CFR 884.xxxx(Obstetrics/Gynecology)240-276-0115
21 CFR 892.xxxx(Radiology)240-276-0120
Other240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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

Enclosure

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INDICATIONS FOR USE STATEMENT 4.

510(k) Number (if known):

Aragon Surgical LapCap Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The Aragon Surgical LapCap is intended for use in the peri-umbilical region of the abdominal wall with a Veress needle for the establishment of a pneumoperitoneum during gynecologic (pelvic) and general surgical (intraabdominal) laparoscopic procedures.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Hest. Plesen

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

Confidential

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