(49 days)
The Socorro SMI Tunnel Release Device is intended for the minimally invasive examination, isolation and recession/incision of ligament, tendons, or fascia as in:
-Plantar Fasciotomy,
-Carpal Tunnel Release,
-Elbow Cubital Tunnel Release and
- -Gastrocnemius Tenotomy.
The SMI Tunnel Release Device is comprised of a hand piece with a tissue cutting probe which is used in conjunction with an endoscope camera and fiber optic illumination system. The device is supplied sterile and is for single use only.
The hand piece provides an actuation member for extending, retracting, and angularly rotating surgical blades which are attached to the distal end of the hand piece. Basic features of these probes are a retraction region and visualization that is nearly threehundred and sixty degrees (360°).
The visualization scope connects with the camera head and optic cables which provide the surgeon a clear and complete view of the surgical site on the overhead monitor.
The endoscope is used to illuminate and visualize the anatomy in or around the operative site. It allows the physician to directly visualize the actions of the probe during the procedure and to verify complete excision of the targeted tissue.
The provided text is a 510(k) summary for the Socorro SMI Tunnel Release Device. It describes the device, its intended use, and its substantial equivalence to a predicate device, supported by bench testing. However, it does not contain detailed acceptance criteria, specific quantitative performance metrics, or a description of a clinical study or even a detailed bench study that would typically include the elements requested in the prompt.
Therefore, many of the requested items cannot be extracted from the provided text. The document focuses on regulatory compliance through substantial equivalence, primarily based on design, materials, and bench testing, rather than a detailed performance study with specific acceptance criteria.
Below is a response attempting to address the prompt based only on the information available in the provided text. Where information is not present, it is explicitly stated.
Acceptance Criteria and Study Details for the Socorro SMI Tunnel Release Device
The provided 510(k) summary for the Socorro SMI Tunnel Release Device (K102219) concludes that the device is substantially equivalent to its predicate device based on intended use, technology, design, and materials, supported by bench testing. However, the document does not explicitly state specific quantitative acceptance criteria or provide a detailed report of the bench testing that demonstrates how these criteria were met.
Instead, the summary states a general conclusion: "Bench testing has demonstrated that the device is in compliance with international standards, the expectations of the medical community and the product labeling." This implies that the device's performance, as evaluated during bench testing, met the necessary standards and expectations to deem it safe and effective for its stated intended use and comparable to the predicate device.
Given the information, we can only infer the 'reported device performance' is that it does meet these implied standards.
1. Table of Acceptance Criteria and the Reported Device Performance:
| Acceptance Criteria (Inferred from "compliance with standards and expectations") | Reported Device Performance (Inferred) |
|---|---|
| Compliance with international standards | Device is in compliance with international standards. |
| Compliance with medical community expectations | Device is in compliance with the expectations of the medical community. |
| Compliance with product labeling | Device is in compliance with the product labeling. |
| Substantial equivalence to predicate device (K080133) in: | Demonstrated substantial equivalence to the A.M. Surgical Mountable Endoscopic Blade (K080133) in intended use, technology, design, and materials. |
| - Intended use | Achieved. |
| - Technology | Achieved. |
| - Design | Achieved. |
| - Materials | Achieved. |
| No unresolved safety or efficacy issues from device differences | The differences in the devices (primarily concerning sterility and single-use status) do not raise any unresolved issues of safety or efficacy. |
2. Sample size used for the test set and the data provenance:
The document mentions "Bench testing has demonstrated...", but does not provide details on the sample size used for this testing or the data provenance (e.g., country of origin, retrospective or prospective). This type of information is typically detailed in the full test report, which is not included in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not describe a study involving expert consensus or ground truth establishment in the context of human expert review. The evaluation relied on bench testing against established standards and predicate device comparison.
4. Adjudication method for the test set:
Not applicable, as no multi-expert review or adjudication process for a test set is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
No MRMC or comparative effectiveness study involving human readers or AI assistance is described in this 510(k) summary. The device is a surgical tool, not an AI diagnostic or assistance system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is a physical surgical tool and does not involve standalone algorithm performance.
7. The type of ground truth used:
For the bench testing, the "ground truth" implicitly refers to the established international standards, medical community expectations, and the performance characteristics of the predicate device. These serve as the benchmarks against which the new device's physical performance (e.g., cutting ability, structural integrity, retraction/rotation mechanisms) would have been validated.
8. The sample size for the training set:
Not applicable. This device is a surgical instrument evaluated through bench testing, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for an algorithm.
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Section 5: 510(k) Summary
K102219 SEP 2 4 2010
| Device Information: | |
|---|---|
| Category | Comments |
| Sponsor: | Socorro Medical, Inc.450 Sutter Street, Suite 500San Francisco, CA 94108Contact: Ed Diao, M.D.ediao@sf-sc.com415-362-8880 |
| Correspondent ContactInformation: | Craig CoombsCoombs Medical Device Consulting1193 Sherman StreetAlameda, CA 94501Tel: 510-337-0140Fax: 510-337-0416 |
| Device Common Name: | Surgical Knife |
| Device Classification & Code: | Class II (due to specific claims, otherwise Class I),EMF |
| Device Classification Name: | 21 CFR 878.4800 |
Socorro SMI Tunnel Release Device
Predicate Device Information:
Device Proprietary Name:
| Predicate Device: | A.M. Surgical Mountable Endoscopic Blade |
|---|---|
| Predicate Device Manufacturer: | A.M. Surgical, Inc. |
| Predicate Device Common Name: | Surgical Knife |
| Predicate Device Classification: | 21 CFR 878.4800 |
| Predicate Device Classification & Code: | Class II, EMF |
| Premarket Notification Number: | K080133 |
b. Date Summary Prepared
18 June 2010
c. Description of Device
The SMI Tunnel Release Device is comprised of a hand piece with a tissue cutting probe which is used in conjunction with an endoscope camera and fiber optic illumination system. The device is supplied sterile and is for single use only.
The hand piece provides an actuation member for extending, retracting, and angularly rotating surgical blades which are attached to the distal end of the hand piece. Basic features of these probes are a retraction region and visualization that is nearly threehundred and sixty degrees (360°).
The visualization scope connects with the camera head and optic cables which provide the surgeon a clear and complete view of the surgical site on the overhead monitor.
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Image /page/1/Picture/0 description: The image shows a logo with the word "SOCORRO" written in a sans-serif font. Above the word is a circular graphic that appears to be a stylized representation of a celestial body, possibly a moon or planet, with craters or surface details visible. The text below "SOCORRO" is illegible due to the image's resolution.
The endoscope is used to illuminate and visualize the anatomy in or around the operative site. It allows the physician to directly visualize the actions of the probe during the procedure and to verify complete excision of the targeted tissue.
d. Intended Use
The Socorro SMI Tunnel Release Device is intended for the minimally invasive examination, isolation and recession/incision of ligament, tendons, or fascia as in:
-Plantar Fasciotomy, -Carpal Tunnel Release, -Elbow Cubital Tunnel Release and -Gastrocnemius Tenotomy.
e. Comparison to Predicate Device
The Socorro SMI Tunnel Release Device is substantially equivalent in intended use, technology, design and materials to the A.M. Surgical Mountable Endoscopic Blade (K080133).
The Socorro SMI Tunnel Release Device and its predicate all provide technology to access and relieve an entrapment neuropathy that occurs when a nerve or tendon at the wrist, elbow, knee, ankle or heel is compressed by a thickened tendon sheath, edema or soft-tissue mass. An endoscope is guided into the joint through a small incision(s) above and/or below the affected joint. Small cutting tools (mechanical blades) are then used to excise the tendon sheath or mass under direct observation.
The patient contacting components that make up the application device and its predicate is stainless steel. The blades are provided sterile and are for single use only. Other components of the predicate device are sterilized between uses while the entire application device is provided sterile and is for single use only.
The testing described below demonstrates that the differences in the devices do not raise any unresolved issues of safety or efficacy.
Socorro Medical concludes that the devices are substantially equivalent.
f. Summary of Supporting Data
Bench testing has demonstrated that the device is in compliance with international standards, the expectations of the medical community and the product labeling.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle faces to the left. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Socorro Medical, Inc. % Coombs Medical Device Consulting Mr. Craig Coombs 1193 Sherman Street Alameda, California 94501
SEP 2 4 2010
Re: K102219
Trade/Device Name: Socorro SMI Tunnel Release Device Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ, EMF Dated: September 20, 2010 Received: September 22, 2010
Dear Mr. Coombs:
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
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Page 2 - Mr. Craig Coombs
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 (reporting of medical device-related 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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
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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Section 4: Indications for Use Statement
510(k) Number (if known):
K102277
SEP 24 2010
Device Name: Socorro SMI Tunnel Release Device
Indications For Use:
The Socorro SMI Tunnel Release Device is intended for the minimally invasive examination, isolation and recession/incision of ligament, tendons, or fascia as in:
-Plantar Fasciotomy,
-Carpal Tunnel Release,
-Elbow Cubital Tunnel Release and
- -Gastrocnemius Tenotomy.
Prescription Use AND/OR X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Neil R. Doyle for nxn
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K|02219
§ 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.