(87 days)
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML.
No.
A Veress needle is used to establish pneumoperitoneum by insufflating carbon dioxide into the peritoneal cavity, which is a preparatory step for laparoscopic procedures, not a therapeutic intervention itself.
No
The device is used to insufflate the peritoneal cavity for surgical procedures, not to diagnose a condition.
No
The device description clearly states it is a physical needle with a spring-loaded stylet mechanism, and the performance studies focus on physical, mechanical, and biocompatibility tests, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for percutaneous insertion into the peritoneal cavity for insufflation during laparoscopic procedures. This is a surgical procedure performed directly on a patient's body.
- Device Description: The description details a needle used for creating pneumoperitoneum, a physical manipulation of the body cavity.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are typically used in a laboratory setting or at the point of care to analyze biological samples.
The Unimax Veress Needle is a surgical instrument used in vivo (within the living body), not in vitro (in glass or outside the living body) for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Unimax Veress Needle is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.
Product codes
HIF, FHO
Device Description
The Unimax Veress Needle is a sterile and single-use product. It incorporated a spring loaded blunt stylet mechanism similar to the needle. It is used to establish peritoneum prior to trocar and cannula insertion in laparoscopic procedures. The Veress Needle, available in 120mm and 150mm lengths, has applications in gynecological laparoscopy and other laparoscopic procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peritoneal cavity
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
A series of in vitro and in vivo preclinical physical, mechanical and biocompatibility tests were performed to assess the safety and effectiveness of the Unimax Veress Needle. The tests listed below were conducted in accordance with ISO 10993-1 Biological evaluation of medical devices- Part 1: Evaluation and testing, ISO 10993-5 Biological Evalustion of medical devices- Part 5: Test for in vitro cytotoxicity, ISO 10993-7 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals, ISO 10993-10 Biological evaluation of medical devices- Part10: Tests for irritation and delayed-type hypersensitivity, ISO 10993-12 Biological evaluation of medical devices- PArt12: Sample preparation and reference material, ISO 11135-1:2007, Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.
- Cytotoxicity Test
- Intracutaneous Reactivity Test
- Maximization Sensitization Test
- EO Sterilization Validation Study Report
- Ethylene Oxide Sterilization Residuals Study Report
The tests listed below have demonstrated that the subject device performs at least same performance as the predicate device.
- Tip Pull Test
- Switch Operation
- Spring Obturator Operation
- Needle Puncture Force Test
All the test results demonstrate the performance of Unimax Veress Needle meets the requirements of its pre-defined acceptance criteria and intended uses.
The results of the non-clinical testing demonstrate that the Unimax Veress Needle is as safe and effective as the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
KIIIIHH
Pg. 1 of 4
Unimax Medical Systems Inc. 510(k) Notification
AUG 1 9 2011
Unimax Veress Needle
510(k) Summary
| 5.1 | Type of Submission: | Traditional |
|---|---|---|
| 5.2 | Preparation Date: | Apr 29, 2011 |
| 5.3 | Revised Date: | Jul 27, 2011 |
| 5.4 | Submitter: | Unimax Medical Systems Inc. |
| Address: | 8F-2, No. 127, Lane 235, Pao Chiao Rd., Hsin Tien, | |
| Taipei, Taiwan | ||
| Phone: | 886-2-89191698 | |
| Fax: | 886-2-89191528 | |
| Contact: | Sophia Chiu | |
| Establishment Registration Number: | 3007791595 |
5.5 Identification of the Device:
| Proprietary/Trade name: | Unimax Veress Needle |
|---|---|
| Common Name: | Veress Needle |
| Classification Name: | Insufflator, Laparoscopi- |
| Device Classification: | 2 |
| Regulation Number: | 884.1730 |
| Panel: | Obstetrics/Gynecology |
| Product Code: | HIF |
5.6 Identification of the Predicate Device:
| Predicate Device Name: | GeniCon Pneumo-Needle |
|---|---|
| Manufacturer: | GeniCon, L.C. |
| 510(k) Number or Clearance Information: | K993625 |
1
Unimax Veress Needle
Image /page/1/Picture/1 description: The image shows the text "Unimax Medical Systems Inc.". The text is in a simple, sans-serif font and is left-aligned. The text is the main focus of the image, and there are no other visual elements present.
5.7 Intended Use and Indications for Use of the subject device.
The Unimax Veress Needle is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.
5.8 Device Description
510(k) Notification
い
The Unimax Veress Needle is a sterile and single-use product. It incorporated a spring loaded blunt stylet mechanism similar to the needle. It is used to establish peritoneum prior to trocar and cannula insertion in laparoscopic procedures. The Veress Needle, available in 120mm and 150mm lengths, has applications in gynecological laparoscopy and other laparoscopic procedures.
5.9 Non-clinical Testing
A series of in vitro and in vivo preclinical physical, mechanical and biocompatibility tests were performed to assess the safety and effectiveness of the Unimax Veress Needle. The tests listed below were conducted in accordance with ISO 10993-1 Biological evaluation of medical devices- Part 1: Evaluation and testing, ISO 10993-5 Biological Evalustion of medical devices- Part 5: Test for in vitro cytotoxicity, ISO 10993-7 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals, ISO 10993-10 Biological evaluation of medical devices- Part10: Tests for irritation and delayed-type hypersensitivity, ISO 10993-12 Biological evaluation of medical devices- PArt12: Sample preparation and reference material, ISO 11135-1:2007, Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.
- · Cytotoxicity Test
- · Intracutaneous Reactivity Test
- · Maximization Sensitization Test
- · EO Sterilization Validation Study Report
- · Ethylene Oxide Sterilization Residuals Study Report
2
KIIIIII
Pg. 3 of 4
Unimax Veress Needle
Unimax Medical Systems Inc. 510(k) Notification
The tests listed below have demonstrated that the subject device performs at least same performance as the predicate device.
- Tip Pull Test
- · Switch Operation
- · Spring Obturator Operation
- · Needle Puncture Force Test
All the test results demonstrate the performance of Unimax Veress Needle meets the requirements of its pre-defined acceptance criteria and intended uses.
The results of the non-clinical testing demonstrate that the Unimax Veress Needle is as safe and effective as the predicate devices.
5.10Substantial Equivalence Determination
The Unimax Veress Needle submitted in this 510(k) file is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared GeniCon Pneumo-Needle which is the subject of K993625. Differences between the devices cited in this section do not raise any new issues of safety or effectiveness.
| Item | Proposed Device
(Unimax Medical Systems Inc. Veress
Needle) | Predicate Device
(GeniCon L.C. Pneumo-Needle) | |
|--------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| Intended Use | The Unimax Veress Needle is intended
for percutaneous insertion into the
peritoneal cavity for the purpose of
insufflation with carbon dioxide to
establish pneumoperitoneum prior to the
placement of trocars during laparoscopic
procedures. | The GeniCon Pneumo-Needle is
intended for percutaneous insertion into
the peritoneal cavity for the purpose of
insufflation with carbon dioxide to
establish pneumoperitoneum prior to
the placement of trocars during
laparoscopic procedures. | |
| | Consisted | Veress Needle | Veress Needle |
| | Instruments | Obturator | Obturator |
| | Models | xVN Series | Model 900-200 |
| | Dimension | 120mm, 150mm | 120mm, 150mm |
3
KIIIIIII
pg.444
Unimax Medical Systems Inc. 510(k) Notification
Unimax Veress Needle
| Sterilization | EO Sterilized | EO Sterilized |
|---|---|---|
| Safety | ||
| standards | ISO 10993-1 | ISO 10993-1 |
| ISO 10993-5 | ISO 10993-5 | |
| ISO 10993-7 | ISO 10993-7 | |
| ISO 10993-10 | ISO 10993-10 | |
| ISO 10993-12 | ISO 10993-12 | |
| ISO 11135-1 | ISO 11135-1 | |
| Performance | ||
| standards | Not Applicable | Not Applicable |
| Compared | ||
| performance | ||
| testing | Tip Pull Test | |
| Switch Operation | Switch Operation | |
| Spring Obturator Operation | Spring Obturator Operation | |
| Needle Puncture Force Test | Needle Puncture Force Test |
5.11 Conclusion
After analyzing bench tests, safety testing data, it can be concluded that Unimax Veress Needle is as safe and effective as the predicate device.
4
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an emblem that resembles an eagle with three lines extending from its back.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Unimax Medical Systems Inc. % Mr. Michael Lee. President AcmeBiotechs Co., Ltd. No.45, Minsheng Rd. Danshui Town TAIPEI COUNTY 251 TAIWAN
Re: K111441
Trade/Device Name: Unimax Veress Needle Regulation Number: 21 CFR§ 884.1730 Regulation Name: Laparoscopic insufflator Regulatory Class: II Product Code: HIF, FHO Dated: May 20, 2011 Received: May 24, 2011
AUG 1 9 2011
Dear Mr. Lee:
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 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
5
Page 2
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,
Hubert Lehman MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K111441
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Unimax Veress Needle is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during 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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hulda Gunn
(Division Sign-Off) Division of Reproductive, Gastro-Rep Urological Devices 510(k) Number
Page 1 of 1