(199 days)
Not Found,
No
The device description and performance studies focus on the mechanical and material properties of a physical needle, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is used to establish pneumoperitoneum for surgical access, which is a preparatory step for a procedure, not a therapeutic intervention itself. It does not treat or cure a disease or condition.
No
This device is used to establish pneumoperitoneum for laparoscopic procedures, not to diagnose a condition.
No
The device description clearly describes a physical, sterile, single-use needle with a spring-loaded mechanism, indicating it is a hardware medical device. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Unimicro Veress Needle is a surgical instrument used to create a space within the body (pneumoperitoneum) for a surgical procedure. It is used on the patient, not for testing samples from the patient.
- Intended Use: The intended use clearly states it's 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." This is a surgical function, not a diagnostic one.
The information provided describes a surgical tool used in laparoscopic procedures, not a device for analyzing biological samples.
N/A
Intended Use / Indications for Use
The Unimicro 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 Unimicro Veress Needle is a sterile and single-use product. It incorporates a spring-loaded blunt stylet mechanism. It is used to establish peritoneum prior to trocar and cannula insertion in laparoscopic procedures. The Unimicro Veress Needle, available in 120 mm and 150 mm 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 Unimicro Veress Needle. The tests listed below were conducted in accordance with ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-7:2008, ISO 10993-10:2010, ISO 10993-12:2012 and ISO 11135-1:2007.
- Cytotoxicity Test .
- Skin irritation Test •
- Skin Sensitization Test ( the Guinea Pig maximization test) .
- EO Sterilization Validation
- . Ethylene Oxide Sterilization Residuals Test
The tests listed below have demonstrated that the subject device performs as well as the predicate device.
- Tip Pull Test .
- Switch Operation •
- Spring Obturator Operation •
- Needle Puncture Force Test .
In each of the above tests, the Unimicro Veress Needle met the requirements of the pre-defined acceptance criteria.
The results of the non-clinical testing demonstrate that the Unimicro Veress Needle is as safe and effective as the predicate device.
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
Image /page/0/Picture/1 description: The image shows the seal of 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 an abstract image of an eagle.
July 31, 2015
Unimicro Medical Systems (ShenZhen) Co., Ltd. Weizhong Chen Vice General Manager 2/f, Bldg 31, The 3rd Industrial Area, Mashantou, Gongming Street, Guangming New District ShenZhen City, Guangdong 518106 China
Re: K150068 Trade/Device Name: Unimicro Veress Needle Regulation Number: 21 CFR 884.1730 Regulation Name: Laparoscopic insufflator Regulatory Class: II Product Code: HIF, FHO Dated: June 17, 2015 Received: June 23, 2015
Dear Weizhong Chen,
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
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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" (21 CFR 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 Industry and Consumer Education 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.
Joyce M. Whang -S
for
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) K150068
Device Name
Unimicro Veress Needle, models : MND 11200, MND 11500
Indications for Use (Describe)
The Unimicro 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.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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3
1 | Unimicro Medical Systems (ShenZhen) Co., Ltd. BIRTHHE 510(K) SUMMARY
This 510(k) summary is being submitted in accordance with 21 CFR §807.92.
Type of submission: Traditional
The assigned 510(K) number is:_ K150068
Date of Preparation: JULY 1, 2015
1. Submitter information:
Manufacturer Name: Unimicro Medical Systems (ShenZhen) Co.,Ltd. Address: 2/F, Bldg 31, The 3rd Industrial Area, Mashantou, Gongming Street, Guangming New District, ShenZhen City,Guangdong Province, China Tel: 0086-755-27111581 Fax: 0086-755-27111580 Establishment Registration Number: 3010806467
2. Contact person:
Mr. Weizhong Chen (Vice General Manager)
E-mail: info@unimicromed.com
3. Identification of the Device :
Trade Name: Unimicro Veress Needle
Common Name: Veress Needle
Model: MND 11200, MND 11500
| Classification
Name | Product
Code | Regulation
Number | Regulatory
Class | Review Panel |
|------------------------------|-----------------|----------------------|---------------------|------------------------------|
| Insufflator,
Laparoscopic | HIF | 21CFR
884.1730 | II | Obstetrics/Gynec
ology |
| Pneumoperitoneum
Needle | FHO | 21CFR
876.1500 | II | Gastroenterology/
Urology |
4
O Unimicro Medical Systems (ShenZhen) Co., Ltd.
4. Identification of the Predicative Device
| Device
Name | Common
Name | Manufacturer | Classification
and Product
Code | Classification
regulation | 510(k)
number |
|----------------------------|------------------|-----------------------------------|---------------------------------------|------------------------------|------------------|
| Unimax
Veress
Needle | Veress
Needle | Unimax
Medical
Systems Inc. | Class II,
HIF | 21CFR
884.1730 | K111441 |
| | | | Class II,
FHO | 21CFR
876.1500 | |
Table 1: Predicative Device Information
5. Indications for Use
The Unimicro 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.
6. Device Description
The Unimicro Veress Needle is a sterile and single-use product. It incorporates a spring-loaded blunt stylet mechanism. It is used to establish peritoneum prior to trocar and cannula insertion in laparoscopic procedures. The Unimicro Veress Needle, available in 120 mm and 150 mm lengths, has applications in gynecological laparoscopy and other laparoscopic procedures.
7. 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 Unimicro Veress Needle. The tests listed below were conducted in accordance with ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-7:2008, ISO 10993-10:2010, ISO 10993-12:2012 and ISO 11135-1:2007.
- Cytotoxicity Test .
- Skin irritation Test •
- Skin Sensitization Test ( the Guinea Pig maximization test) .
5
Co., Ltd.
- EO Sterilization Validation
- . Ethylene Oxide Sterilization Residuals Test
The tests listed below have demonstrated that the subject device performs as well as the predicate device.
- Tip Pull Test .
- Switch Operation •
- Spring Obturator Operation •
- Needle Puncture Force Test .
In each of the above tests, the Unimicro Veress Needle met the
requirements ofthe pre-defined acceptance criteria.
The results of the non-clinical testing demonstrate that the Unimicro Veress Needle is as safe and effective as the predicate device.
8. Substantial Equivalence Determination
The Unimicro 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 Unimax Veress Needle which is the subject of K111441. There are no differences between the two devices that raise any new issues of safety or effectiveness.
The comparison to predicate device as below Table 2.
| Item | Proposed Device | Predicate Device | ||
|---|---|---|---|---|
| Trade Name | Unimicro Veress Needle | Unimax Veress Needle | ||
| 510(K) Submitter | Unimicro Medical Systems | Unimax Medical Systems Inc. | ||
| (ShenZhen) Co.,Ltd. | ||||
| 510(K) Number | K111441 | |||
| Classification | 21CFR 884.1730 | 21CFR 884.1730 | ||
| regulation | 21 CFR 876.1500 | 21 CFR 876.1500 | ||
| Classification | ||||
| and | Class II , | Class II , | ||
| Code | HIF,FHO | HIF,FHO | ||
| Common name | Veress Needle | Veress Needle | ||
| Intended Use | The Unimicro Veress Needle | The Unimax Veress Needle is |
Table 2 : Comparison to Predicate Device
6
ШПіШіСГ © Unimicro Medical Systems (ShenZhen) Co., Ltd.
| | 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. | 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 | MND 11200,MND 11500 | xVN Series |
| Length | 120mm,150mm | 120mm,150mm |
| Sterilization | EO Sterilized | EO Sterilized |
| Disposable | Yes | Yes |
| Principles of operation | Connect the device to the
insufflators with insufflation
tubing, insufflating with
carbon dioxide to establish
pneumoperitoneum | Connect the device to the
insufflators with insufflation
tubing, insufflating with
carbon dioxide to establish
pneumoperitoneum |
| Safety standards | ISO 10993-1:2009
ISO 10993-5:2009
ISO 10993-7:2008
ISO 10993-10:2010
ISO 10993-12:2012
ISO 11135-1:2007 | ISO 10993-1
ISO 10993-5
ISO 10993-7
ISO 10993-10
ISO 10993-12
ISO 11135-1 |
| Performance standards | Not Applicable | Not Applicable |
| Compared performance testing | • Tip Pull Test
• Switch Operation
• Spring Obturator Operation | • Tip Pull Test
• Switch Operation
• Spring Obturator Operation |
7
| Image: Unimicro Medical Systems (ShenZhen) Co., Ltd. | |
|---|---|
| • Needle Puncture Force | • Needle Puncture Force |
Test
Test
9. Conclusion
Based upon the non-clinical performance and safety tests, it can be concluded that the Unimicro Veress Needle is as safe and effective as the predicate device. Therefore, Unimicro Veress Needle is substantially equivalent to the Unimax Veress Needle.