(106 days)
Not Found
No
The 510(k) summary describes a mechanical device for insufflation and suture closure, with no mention of AI or ML capabilities in its intended use, device description, or performance studies.
No
The device is used for surgical access and wound closure, facilitated by insufflation and suture capture, not directly for treating a disease or condition.
No
The device is described as being used for insufflation, creation of pneumoperitoneum, and wound closure, none of which involve diagnosing a medical condition.
No
The device description clearly outlines physical components such as a cannula, stylet, and needle point, indicating it is a hardware device used for surgical procedures.
Based on the provided information, the StarFin 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.
- StarFin's Intended Use: The StarFin device is intended for surgical procedures (insufflation for laparoscopy and wound closure). It is used directly on the patient's body during surgery, not for testing samples taken from the body.
- Device Description: The description clearly outlines a surgical instrument used for creating pneumoperitoneum and facilitating suture placement, not a device for analyzing biological samples.
Therefore, the StarFin device falls under the category of a surgical instrument or device used in vivo (within the living body), not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The StarFin device is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperioneum for laparoscopic procedures prior to the placement of trocars. The StarFin device is also used for suture capture, externalization and internalization for wound closure after laparoscopic surgery.
Product codes (comma separated list FDA assigned to the subject device)
HIF, GCJ
Device Description
The subject device is a single-use, sterile, laparoscopic needle that is used for percutaneous introduction of a hollow stylet into the abdomen for gas insufflation and establishment of pneumoperitoneum prior to abdominal endoscopy and for closure of trocar site wounds with suture threads.
The subject device is equipped with a stainless steel cannular consisting of a beveled needle point for cutting through tissues. Inside the cannula, there is a spring-loaded inner stylet with a rounded blunt tip used for puncture protection. The hollow stainless steel inner stylet provides passing carbon dioxide gas to create pneumoperitoneum. The inner stylet tip is designed for suture capture, passing, externalization, and internalization for wound closure after laparoscopic surgery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peritoneal cavity (abdomen)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional healthcare
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)
Non-Clinical Performance Data:
a. Biocompatibility Test: The stainless-steel outer cannula and inner stylet of the subject device are the components in contact with human tissue for less than 24-hours. The following tests were completed and met the requirements, in accordance with: ISO 10993-5, 2009, Cytotoxicity Test; ISO 10993-10, 2021, Maximization/Sensitization Test; ISO 10993-10, 2021, Irritation/Intracutaneous Reactivity Test; ISO 10993-11, 2017, Acute Systemic Toxicity Test; ISO 10993-11, 2017/USP, Material Mediated Pyrogenicity Test.
b. Sterilization Validation: The sterilization validation was performed and verified according to ISO 11135:2014. The EO and ECH residual of the subject device were evaluated and verified in accordance with ISO10993-7:2008.
c. Bench Performance Tests: The subject device was tested to demonstrate it meets stated performance expectations and compared with the predicate devices. The tests included appearance, size, gas flow rate, gas leak rate, puncture force, suture retention force, stylet pull strength. The tests were also conducted with aged sample (accelerated aging equivalent to 1 year per ASTM F1980) and compared with non-aged samples to demonstrate 1 year shelf-life.
The simulated use of subject device was evaluated and compared with the predicate devices on an artificial skin/fascial sample by qualified and trained laparoscopic surgeons.
Key Results: The non-clinical performance data demonstrate that the subject device is as safe and effective as the predicate devices and support the subject device is substantially equivalent to the predicate devices.
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.
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 29, 2023
Premium Medical Technology LLC Kuowei Chang Managing Director 1377 Main Street 2nd Floor Waltham, Massachusetts 02451
Re: K231407
Trade/Device Name: StarFin Regulation Number: 21 CFR 884.1730 Regulation Name: Laparoscopic Insufflator Regulatory Class: II Product Code: HIF, GCJ Dated: July 25, 2023 Received: August 1, 2023
Dear Kuowei Chang:
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. 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 located 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.
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
1
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) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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
2
Indications for Use
510(k) Number (if known) K231407
Device Name StarFin
Indications for Use (Describe)
The StarFin device is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperioneum for laparoscopic procedures prior to the placement of trocars. The StarFin device is also used for suture capture, externalization and internalization for wound closure after laparoscopic surgery.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(K) Summary
1. Submitter Information
. 510(K) Submitter:
Premium Medical Technology LLC 1377 Main Street, 2nd Floor Waltham, MA 02451-1624, USA
- Contact: . Kuowei Chang, Ph.D. Chief Scientific Officer Phone: 1-781-891-4201 Email: kchang@PremiumMedTech.com
- Date Prepared: . August 28, 2023
-
- Device Information
Name: StarFin Model: StarFin-120 Common Name: Veress needle and Endoscopic Suture Passer Regulation Number: 21 CFR 884 1730 Regulation Name: Laparoscopic Insufflator Product Code: HIF and GCJ Regulatory Class: Class II
-
- Predicate Devices
510(K): K193339 Device Name: GTK Veress Needle
- Predicate Devices
510(K): K954853 Device Name: Endo-Close™ Auto-Suture™ Trocar Site Closure Device
The predicates have not been subject to a design-related recall
-
- Device Description
4
The subject device is a single-use, sterile, laparoscopic needle that is used for percutaneous introduction of a hollow stylet into the abdomen for gas insufflation and establishment of pneumoperitoneum prior to abdominal endoscopy and for closure of trocar site wounds with suture threads.
The subject device is equipped with a stainless steel cannular consisting of a beveled needle point for cutting through tissues. Inside the cannula, there is a spring-loaded inner stylet with a rounded blunt tip used for puncture protection. The hollow stainless steel inner stylet provides passing carbon dioxide gas to create pneumoperitoneum. The inner stylet tip is designed for suture capture, passing, externalization, and internalization for wound closure after laparoscopic surgery.
The environment of use is professional healthcare.
5. Indication for Use
The StarFin device is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum for laparoscopic procedures prior to the placement of trocars. The StarFin device is also used for suture capture, passing, externalization and internalization for wound closure after laparoscopic surgery.
6. Comparison of the Technological Characteristics
Table below provides comparison of technological characteristics between Subject Device and Predicate Devices:
| Items | Subject Device
Dual-Function | Predicate K193339
Single-Function | Predicate K954853
Single-Function | Comments |
|------------------------------------------------|-------------------------------------------------------------------|-------------------------------------------------|--------------------------------------|----------|
| Product
Description
&
Intended
Use | Combination Veress
Needle
&
Trocar Site Wound
Closure | Veress Needle | Trocar Site Wound
Closure | Same |
| Model
Number | StarFin-120 | VN-120 | 173022 | / |
| Manufacturer | Premium Medical
Technology LLC | Guangzhou T.K
Medical Instrument
Co. Ltd. | Covidien LLC | / |
| Classification | Class II | Class II | Class II | Same |
| Product Code | HIF & GCJ | HIF & FHO | GCJ | / |
| Cutting Point | C=Bevel | C=Bevel | C=Bevel | Same |
5
| Spring loaded
| (Inner Stylet) | Yes | Yes | Yes | Same |
|---|---|---|---|---|
| Valve | ||||
| Controlled | Yes | Yes | No | Same |
| Needle | ||||
| Material | 304 Stainless Steel | 304 Stainless Steel | 304 Stainless Steel | Same |
| Handle | ||||
| Material | polyphenylsulfone | polycarbonate | ABS plastic and | |
| polyethylene | Different | |||
| Shape of the | ||||
| suture passer | A needle with a dull, | |||
| blunt hook | N/A | A needle with a dull, | ||
| blunt hook | Same | |||
| Sterilization | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | Same |
The subject and predicate devices have the same intended use. The subject device's intended use is the combination of the intended use of the predicate devices. The subject and predicate device have different technological features, including the needle diameter, length, and handle material. These technological differences do not raise different questions of safety or effectiveness.
7. Non-Clinical Performance Data
The following data were provided in support of the substantial equivalence determination.
a. Biocompatibility Test
The stainless-steel outer cannula and inner stylet of the subject device are the components in contact with human tissue for less than 24-hours. The following tests were completed and met the requirements, in accordance with:
ISO 10993-5, 2009, Cytotoxicity Test
ISO 10993-10, 2021, Maximization/Sensitization Test
ISO 10993-10, 2021, Irritation/Intracutaneous Reactivity Test
ISO 10993-11, 2017, Acute Systemic Toxicity Test
ISO 10993-11, 2017/USP, Material Mediated Pyrogenicity Test
b. Sterilization Validation
The sterilization validation was performed and verified according to ISO 11135:2014. The EO and ECH residual of the subject device were evaluated and verified in accordance with ISO10993-7:2008.
c. Bench Performance Tests
The subject device was tested to demonstrate it meets stated performance expectations and compared with the predicate devices. The tests included appearance, size, gas flow rate, gas leak rate, puncture force, suture retention force, stylet pull strength. The tests were also conducted with aged sample (accelerated
6
aging equivalent to 1 year per ASTM F1980) and compared with non-aged samples to demonstrate 1 year shelf-life.
The simulated use of subject device was evaluated and compared with the predicate devices on an artificial skin/fascial sample by qualified and trained laparoscopic surgeons.
8. Conclusions
The non-clinical performance data demonstrate that the subject device is as safe and effective as the predicate devices and support the subject device is substantially equivalent to the predicate devices.