(126 days)
Not Found
No
The summary describes a mechanical surgical instrument with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is used to establish pneumoperitoneum for laparoscopic procedures, which is a preparatory step for surgery, not a direct therapeutic intervention for a disease or condition.
No
Explanation: The device is intended for insufflation to establish pneumoperitoneum for laparoscopic procedures, which is a preparatory step for surgery, not a diagnostic one.
No
The device description explicitly details physical components made of medical-grade materials (stainless steel, PC, PE, ABS, silicone sleeve) and mentions manufacturing processes like sterilization and packaging, 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 the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars opic procedures." This describes a surgical procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a needle used for insufflation during laparoscopic procedures. It is a surgical instrument.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or to provide diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Disposable Veress Needles are 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
Device Description
The Disposable Veress Needles are composed of needle, inner core, handle and made of medical grade stainless steel, PC, PE, ABS, and Model II has a silicone sleeve on the handle. The device is packed in Tyvek dialysis bag with 4058B Tyvek dialysis paper and ESE film. The contact duration is less than 24 hours. The device 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 device is sterilized by EO and is intended for single-use only. The proposed device is available in a variety of needle lengths.
There are two models for Disposable Veress needles: I, II. The difference between the two models is that the model II has a blue silicone sleeve outside the handle.
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
The tests listed below have demonstrated that the subject device performs as well as the predicate device based on the acceptance criteria:
- -Tip Pull Test
- -Switch Operation
- -Spring Obturator Operation
- -Needle Puncture Force Test
Biocompatibility testing:
Biocompatibility of the Disposable Veress Needles was evaluated in accordance with ISO 10993-1, Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process. Testing included:
Cytotoxicity ISO 10993-5:2009
Skin Sensitization ISO 10993-10:2021
Intracutaneous Reactivity ISO 10993-23:2021
Acute Systemic Toxicity ISO 10993-11:2017
Pyrogenicity ISO 10993-11:2017
Sterilization Validation and Shelf-life Testing:
Sterilization was validated in accordance with ISO 11135:2014. Sterilant residuals were evaluated in accordance with ISO 10993-7:2019.
Combined simulated shipping distribution, stability, and packaging integrity testing was performed in accordance with the 2016 FDA guidance document, Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile: Guidance for Industry and Food and Drug Administration Staff. Testing included:
Simulated distribution testing ASTM D4169
Packaging integrity testing ASTM F1886/F1886M-16 ASTM F88/F88M-15 ASTM F1929-15
The 3 year shelf-life of the device was determined based on stability of package integrity and performance testing after aging per ASTM F1980-21.
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
December 14, 2023
Hangzhou Kangji Medical Instrument Co., Ltd. % Esther Zhang Official Correspondent Shanghai Ling Fu Technology Co., Ltd. 4F No. 585-2. Wanyuan Rd. Minhang District Shanghai, Shanghai 201102 China
Re: K232401
Trade/Device Name: Disposable Veress Needles Regulation Number: 21 CFR§ 884.1730 Regulation Name: Laparoscopic Insufflator Regulatory Class: II Product Code: HIF Dated: November 13, 2023 Received: November 16, 2023
Dear Esther Zhang:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
2
3
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jason Roberts -S
Jason R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K232401
Device Name Disposable Veress Needles
Indications for Use (Describe)
Disposable Veress Needles
The Disposable Veress Needles are 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 opic procedures.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | ☑ |
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
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4
510(k) Summary Disposable Veress Needles K232401
1. Submitter Information
Hangzhou Kangji Medical Instrument Co., Ltd. No. 1668 Chunjiang East Road Economic Development Zone, Tonglu, Hangzhou, 311501 China Contact person: Martin Sun Manager of Regulatory Affairs Phone: +86-0571-69901712 Fax: +86-0571-69901712 Email: martin.sun@kangji.com
2. Submission Correspondent
Shanghai Ling Fu Technology Co., Ltd. 4F No. 585-2, Wanyuan Rd. Minhang District, Shanghai, P.R. China Contact person: Esther Zhang Email: Esther.zhang@llins-tech.com
3. Date Prepared
December 13, 2023
4. Device Identification
| Trade Name of Device: | Disposable Veress Needles |
|---|---|
| Common Name: | Veress Needle |
| Model: | I, II |
| Regulation Name: | Laparoscopic Insufflator |
| Regulation Number: | 884.1730 |
| Product Code: | HIF (Insufflator, Laparoscopic) |
| Class: | Class II |
5. Legally Marketed Predicate Device
| Trade Name: | Unimicro Veress Needle |
|---|---|
| Common Name: | Veress Needle |
| Manufacturer: | Unimicro Medical Systems (ShenZhen) Co., Ltd. |
| Regulation Name: | Laparoscopic Insufflator; |
| Regulation Number: | 884.1730 |
| Product Code: | HIF, FHO |
5
510(k) number: K150068 Class: 11
The predicate device has not been subject to a design-related recall.
6. Device Description
The Disposable Veress Needles are composed of needle, inner core, handle and made of medical grade stainless steel, PC, PE, ABS, and Model II has a silicone sleeve on the handle. The device is packed in Tyvek dialysis bag with 4058B Tyvek dialysis paper and ESE film. The contact duration is less than 24 hours. The device 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 device is sterilized by EO and is intended for single-use only. The proposed device is available in a variety of needle lengths.
There are two models for Disposable Veress needles: I, II. The difference between the two models is that the model II has a blue silicone sleeve outside the handle.
7. Indication for Use
The Disposable Veress Needles are intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to placement of trocars during laparoscopic procedures.
8. Comparison of technological characteristics with the predicate device
| | Disposable Veress Needles | Unimicro Veress Needle
K150068 | Discussion |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Manufacturer | Hangzhou Kangji Medical
Instrument Co., Ltd. | Unimicro Medical Systems
(ShenZhen) Co., Ltd. | |
| Product Code | HIF | HIF, FHO | Same |
| Regulation Number | 884.1730 | 884.1730, 876.1500 | Same |
| Class | Class II | Class II | Same |
| Indications for Use | The Disposable Veress
Needles are 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 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 trocs during
laparoscopic procedures | Same |
| Conditions of Use | Rx Only; Single Use Only | Rx Only; Single Use Only | Same |
| Sterilization | Ethylene Oxide | Ethylene Oxide | Same |
| Models | I, II | MDN 11200, MND 11500 | Different: The subject
device is available in
different models than
the predicate device |
Table 1. Comparison of Characteristics
6
| | | | based on length and,
for Model II of the
subject device, a
silicone sleeve on the
handle. This difference
does not raise different
questions of safety and
effectiveness (S&E). |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Lengths | 110±4mm, 120±4mm,
130±4mm, 140±4mm,
150±4mm | 120mm, 150mm | Different: The subject
device is available in
more lengths than the
predicate. This
difference does not
raise different
questions of S&E. |
| Components | Needle, Inner core, Handle,
and Valve | Veress Needle, Obturator | Same |
| Needle Material | Stainless Steel | Stainless Steel | Same |
| Handle Material | PC | ABS | Different: The subject
device handle material
is different than the
predicate device. This
does not raise different
questions of S&E. |
| Principles of
Operation | Connect the device to the
insuffators with tubing,
insufflate with carbon dioxide
to establish
pneumoperitoneum. | Connect the device to the
insuffators with tubing,
insufflate with carbon dioxide
to establish
pneumoperitoneum. | Same |
As shown in the table above, there are differences in the lengths and materials of the subject and predicate devices. However, as stated in the table, the differences in technological features do not raise different questions of safety and effectiveness.
9. Summary of Non-Clinical Testing
The tests listed below have demonstrated that the subject device performs as well as the predicate device based on the acceptance criteria:
- -Tip Pull Test
- -Switch Operation
- -Spring Obturator Operation
- -Needle Puncture Force Test
Biocompatibility testing
Biocompatibility of the Disposable Veress Needles was evaluated in accordance with ISO 10993-1, Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process. Testing included:
7
| Cytotoxicity | ISO 10993-5:2009 |
|---|---|
| Skin Sensitization | ISO 10993-10:2021 |
| Intracutaneous Reactivity | ISO 10993-23:2021 |
| Acute Systemic Toxicity | ISO 10993-11:2017 |
| Pyrogenicity | ISO 10993-11:2017 |
Sterilization Validation and Shelf-life Testing
Sterilization was validated in accordance with ISO 11135:2014. Sterilant residuals were evaluated in accordance with ISO 10993-7:2019.
Combined simulated shipping distribution, stability, and packaging integrity testing was performed in accordance with the 2016 FDA guidance document, Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile: Guidance for Industry and Food and Drug Administration Staff. Testing included:
Simulated distribution testing ASTM D4169 Packaging integrity testing ASTM F1886/F1886M-16 ASTM F88/F88M-15 ASTM F1929-15
The 3 year shelf-life of the device was determined based on stability of package integrity and performance testing after aging per ASTM F1980-21.
10. Statement of Substantial Equivalence
The Disposable Veress Needles are substantially equivalent to the predicate device (Unimicro Veress Needle). The technological differences between the predicate and subject device do not raise different questions of safety or effectiveness. The results of the performance testing described above demonstrate that the subject device is as safe and effective as the predicate device.