(158 days)
The Unimax Specimen Retrieval System is indicated for use as a receptacle for the collection and extraction of tissue, organs and calculi during general and laparoscopic surgical procedures.
The Unimax Specimen Retrieval System is a sterile and single-use specimen container designed for use in retrieving specimens during endoscopic surgery. The Unimax Specimen Retrieval System is supplied in a dispending tube for ease of insertion through a standard 10, 11 or 12mm trocar sheath.
This is a medical device, not an AI/ML device. Therefore, the questions related to AI/ML device performance and studies are not applicable.
Here's an analysis of the provided text regarding the Unimax Specimen Retrieval System:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (K103510) is a 510(k) premarket notification for a medical device. For such devices, acceptance criteria are typically established through a series of non-clinical tests to demonstrate safety and effectiveness. The document refers to "pre-defined acceptance criteria" but does not explicitly list these criteria or their specific values. Instead, it states that the device "meets the requirements of its pre-defined acceptance criteria."
The performance is described relative to a predicate device (Applied Medical Resources Corporation Specimen Retrieval System, K100959), asserting "substantial equivalence."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| In vitro & In vivo Preclinical Physical Tests | "All the test results demonstrate the performance of Unimax Specimen Retrieval System meets the requirements of its pre-defined acceptance criteria and intended uses." |
| In vitro & In vivo Preclinical Mechanical Tests | "All the test results demonstrate the performance of Unimax Specimen Retrieval System meets the requirements of its pre-defined acceptance criteria and intended uses." |
| Biocompatibility Tests | "All the test results demonstrate the performance of Unimax Specimen Retrieval System meets the requirements of its pre-defined acceptance criteria and intended uses." (References ISO 10993-1, -10, -12 for evaluation framework) |
| Overall Safety and Effectiveness | "The result of bench testing indicates that the new device is as safe and effective as the predicate device." |
| Substantial Equivalence | "The Unimax Specimen Retrieval System...is substantially equivalent in intended use, design, principles of operation, materials and performance to the cleared Applied Medical Specimen Retrieval System..." |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "a series of in vitro and in vivo preclinical physical, mechanical and biocompatibility tests" but does not specify the sample sizes used for these test sets. The data provenance is generally "bench testing" and "in vitro and in vivo preclinical tests," which are types of lab or animal studies, not human clinical trial data. There's no indication of country of origin for the internal testing data, but the submitter's address is in Taipei, Taiwan. The studies were prospective in the sense that they were conducted specifically to support this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For non-clinical tests on a medical device like this, ground truth is typically established against engineering specifications, material standards, and biological safety standards (like ISO 10993). It is not usually established by human expert consensus in the way it would be for an AI diagnostic tool.
4. Adjudication Method for the Test Set
This is not applicable as the tests are non-clinical and objective, based on measurements against predefined criteria and standards rather than human interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, a MRMC comparative effectiveness study was not done. This type of study is relevant for AI image analysis or diagnostic tools, not for a physical specimen retrieval system. Therefore, an effect size of human improvement with AI assistance is not relevant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
No, a standalone algorithm study was not done. This device is a physical surgical tool and does not involve an algorithm.
7. The Type of Ground Truth Used
The ground truth for the non-clinical tests (physical, mechanical, biocompatibility) would be based on established engineering specifications, material science standards, and accepted biological safety standards (e.g., ISO 10993). For instance, a tensile strength test would have a pre-defined ground truth for the minimum acceptable strength. Biocompatibility would be evaluated against the absence of adverse biological reactions as defined by ISO standards.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical device, not an AI/ML system that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. (See point 8).
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MAY - 6 2011
Page 1 of 4
Unimax Medical Systems Inc. 510(k) Notification
Unimax Specimen Retrieval System
510(k) Summary
- Traditional Type of Submission: 5.1
| 5.2 | Submitter: | Unimax Medical Systems Inc. |
|---|---|---|
| Address: | 8F-2, No. 127, Lane 235, Pao Chiao Rd., Hsin Tien City, | |
| Taipei, Taiwan | ||
| Phone: | 886-2-89191698 | |
| Fax: | 886-2-89191528 | |
| Contact: | Sophia Chiu | |
| Establishment Registration Number: | 3007791595 |
- Identification of the Device: 5.3 Proprietary/Trade name: Common Name: Classification Name: Device Classification: Regulation Number:
Panel:
Product Code:
Unimax Specimen Retrieval System Tissue Bags laparoscope, general & plastic surgery II 876.1500 General & Plastic Surgery GCJ
5.4 Identification of the Predicate Device:
| Predicate Device Name: | Specimen Retrieval System |
|---|---|
| Manufacturer: | Applied Medical Resources Corporation |
| 510(k) Number or Clearance Information: | K100959 |
5.5 Intended Use and Indications for Use of the subject device.
The Unimax Specimen Retrieval System is indicated for use as a receptacle for the collection and extraction of tissue, organs and calculi during general and laparoscopic surgical procedures.
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Page 2 of (4)
Unimax Medical Systems Inc. 510(k) Notification
Unimax Specimen Retrieval System
5.6 Device Description
The Unimax Specimen Retrieval System is a sterile and single-use specimen container designed for use in retrieving specimens during endoscopic surgery. The Unimax Specimen Retrieval System is supplied in a dispending tube for ease of insertion through a standard 10, 11 or 12mm trocar sheath.
5.7 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 Unimax Specimen Retrieval System. All the test results demonstrate the performance of Unimax Specimen Retrieval System meets the requirements of its pre-defined acceptance criteria and intended uses. The results of the non-clinical testing demonstrate that the Unimax Specimen Retrieval System is as safe and effective as the predicate devices.
5.8 Safety and Effectiveness
The result of bench testing indicates that the new device is as safe and effective as the predicate device.
5.9 Substantial Equivalence Determination
The Unimax Specimen Retrieval System submitted in this 510(k) file is substantially equivalent in intended use, design, principles of operation, materials and performance to the cleared Applied Medical Specimen Retrieval System which is the subject of K100959. Differences between the devices cited in this section do not raise any new issues of safety or effectiveness.
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K 103510
Page 3 of 4
Unimax Medical Systems Inc.
510(k) Notification
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..............................................................................................................................................................................
Unimax Specimen Retrieval System
| Item | Predicate Device(Applied Medical ResourcesCorporation Specimen RetrievalSystem) | Proposed Device(Unimax Medical Systems IncSpecimen Retrieval System) |
|---|---|---|
| Similarity | ||
| Intended Use | Indicated for use as a receptacle forthe collection and extraction oftissue, organs and calculi duringgeneral and laparoscopic surgicalprocedures. | Same |
| Material | Various PolymerStainless | Same |
| Specification | consists of a flexible polymer bagand an introducer structure that fitsthrough a trocar port | Same |
| Biocompatibility | ISO 10993-1: 2003, Biologicalevaluation of medical devices --Part 1: Evaluation and testingISO 10993-10: 2002, Biologicalevaluation of medical devices - Part10: Tests for irritation anddelayed-type hypersensitivityISO 10993-12: 2007, Biologicalevaluation of medical devices --Part 12: Sample preparation andreference materials | Same |
| Difference | ||
| Sterilization | gamma irradiation, SterilityAssurance Level will be 10-6 | EtO Sterilization |
18
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K10 3510
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Page 4 96
Unimax Medical Systems Inc. 510(k) Notification
Unimax Specimen Retrieval System
5.10 Conclusion
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After analyzing bench tests, it can be concluded that Unimax Specimen Retrieval System is as safe and effective as the predicate device.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY - 6 2011
Unimax Medical Systems, Inc. % Acmebiotechs Co., Ltd. Mr. Michael Lee No. 45, Minshen Road, Danshui Town Taipei County (Taiwan) 251 China
Re: K103510
Trade/Device Name: Unimax Specimen Retrieval System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: April 11, 2011 Received: April 11, 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. Iisting 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
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Page 2 - Mr. Michael Lee
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 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/ReportalProblem/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.
My B. nh
for
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Unimax Medical Systems Inc. 510(k) Notification
Unimax Specimen Retrieval System
Indications for Use
510(k) Number (if known):
Device Name: Unimax Specimen Retrieval System
Indications for Use:
The Unimax Specimen Retrieval System is indicated for use as a receptacle for the collection and extraction of tissue, organs and calculi during general and laparoscopic surgical procedures.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (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)
Neil R.P. Ogden for mxm
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of
510(k) Number K103510
7
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.