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.

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.

The environment of use is professional healthcare.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the StarFin device, a laparoscopic insufflator and suture passer. However, it does not contain the specific information required to complete the table and answer all the questions regarding acceptance criteria and the study proving the device meets them.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through:

Comparison of technological characteristics: This highlights similarities and differences in design, materials, and intended use.
Non-clinical performance data: This includes biocompatibility, sterilization validation, and bench performance tests.

Crucially, it does not include:

Quantitative acceptance criteria for device performance (e.g., minimum gas flow rate, maximum leak rate).
Reported device performance against those specific criteria.
Details about a clinical study, reader study, or other method to prove the device meets acceptance criteria in a real-world or simulated clinical setting with a defined ground truth and statistical analysis. The mention of "simulated use" with qualified surgeons is too brief to extract the requested details.
Information on sample sizes for test sets, training sets, data provenance, expert qualifications, or adjudication methods for establishing ground truth as would be present in a comprehensive study report.
Any details about a multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance, as the device is mechanical, not AI-based.

Therefore, many of the requested fields cannot be populated from the given text.

Based on the provided text, here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

Cannot be fully provided. The document mentions "bench performance tests" including "appearance, size, gas flow rate, gas leak rate, puncture force, suture retention force, stylet pull strength." It states these tests "met stated performance expectations" and were "compared with the predicate devices," but it does not provide the specific quantitative acceptance criteria or the reported performance values for the StarFin device for these parameters.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be provided. The document refers to "bench performance tests" and "simulated use," but does not specify sample sizes for these tests, nor their provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Cannot be provided definitively. For the "simulated use," it states it was evaluated by "qualified and trained laparoscopic surgeons." The number of surgeons or their specific qualifications (e.g., years of experience) are not mentioned. There is no explicit "ground truth" establishment described beyond the surgeons' evaluation during simulated use.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Cannot be provided. No adjudication method is mentioned for any of the described tests, including the "simulated use."

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable / Cannot be provided. The StarFin device is a mechanical medical device (laparoscopic insufflator and suture passer), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance would not be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable / Cannot be provided. As a mechanical device, there is no "algorithm only" performance to evaluate.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Limited information. For the "bench performance tests," the ground truth would be engineering specifications and predicate device performance. For the "simulated use," the implied ground truth is the assessment and opinion of "qualified and trained laparoscopic surgeons" during the simulation. No other formal types of ground truth (e.g., pathology, outcomes data) are mentioned.

8. The sample size for the training set

Not applicable / Cannot be provided. The device is mechanical. There is no "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established

Not applicable / Cannot be provided. As there is no training set for a mechanical device, no ground truth establishment for it is relevant or described.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K231407

Device Name StarFin

Indications for Use (Describe)

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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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
1. 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

1. Predicate Devices
  510(K): K193339 Device Name: GTK Veress Needle

510(K): K954853 Device Name: Endo-Close™ Auto-Suture™ Trocar Site Closure Device

The predicates have not been subject to a design-related recall

1. Device Description

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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 DeviceDual-Function	Predicate K193339Single-Function	Predicate K954853Single-Function	Comments
ProductDescription&IntendedUse	Combination VeressNeedle&Trocar Site WoundClosure	Veress Needle	Trocar Site WoundClosure	Same
ModelNumber	StarFin-120	VN-120	173022	/
Manufacturer	Premium MedicalTechnology LLC	Guangzhou T.KMedical InstrumentCo. 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

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Spring loaded(Inner Stylet)	Yes	Yes	Yes	Same
ValveControlled	Yes	Yes	No	Same
NeedleMaterial	304 Stainless Steel	304 Stainless Steel	304 Stainless Steel	Same
HandleMaterial	polyphenylsulfone	polycarbonate	ABS plastic andpolyethylene	Different
Shape of thesuture 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<151>, 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

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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.

Regulation Number and Section

§ 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.