(128 days)
Not Found
Not Found
No
The 510(k) summary describes a pneumoperitoneum needle, a mechanical device used to create a space for endoscopic procedures. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the provided text.
No
The device is used for establishing pneumoperitoneum during surgical procedures, which is a preparatory step for diagnosis or treatment, not a therapeutic intervention itself.
No
The device is described as a "Pneumoperitoneum Needle" used for the establishment of a pneumoperitoneum in endoscopic procedures, which is a therapeutic or procedural function, not a diagnostic one.
No
The device is described as a "Pneumoperitoneum Needle," which is a physical medical device used to establish pneumoperitoneum. The description does not mention any software component as the primary or sole function of the device.
Based on the provided information, the Medline Pneumoperitoneum Needle is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for establishing a pneumoperitoneum during gynecologic and abdominal endoscopic procedures. This is a surgical procedure performed on the patient's body, not a test performed on a sample taken from the body.
- IVD Definition: In Vitro Diagnostics are tests performed on samples such as blood, urine, or tissue, outside of the body, to detect diseases, conditions, or infections.
The description clearly indicates a device used directly in a surgical setting on a living patient, which is the opposite of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Medline Pneumoperitoneum Needle has applications in gynecologic and abdominal endoscopic procedures for establishment of a pneumoperitoneum.
Product codes
HIF, FHO
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
gynecologic and abdominal
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Matt Clausen Regulatory Affairs Specialist Medline Industries, Inc. One Medline Place Mundelein, IL 60060
JUL 2 7 2015
Re: K11955
Trade/Device Name: Medline Pneumoperitoneum Needle Regulation Number: 21 CFR§ 884.1730 Regulation Name: Laparoscopic insufflator Regulatory Class: II Product Code: HIF, FHO Dated (Date on orig SE ltr): October 27, 2011 Received (Date on orig SE ltr): November 2, 2011
Dear Mr. Clausen.
This letter corrects our substantially equivalent letter of November 16, 2011.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
1
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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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office
of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known):
K III 955
Device Name:
Medline Pneumoperitoneum Needle
Indications For Use:
The Medline Pneumoperitoneum Needle has applications in gynecologic and abdominal endoscopic procedures for establishment of a pneumoperitoneum.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) | |
| OR | |
| Over-the-Counter Use | |
| (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of GDRH, Office of Device Evaluation (ODE)
۳۰
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K111955