(64 days)
The Space-OR Retractor is a flexible internal retractor intended for the retraction of organs and tissues during abdominal surgery.
The Space-OR is a flexible retractor which can be formed by the user into the desired shape for retraction of organs or tissues during abdominal surgery. The Space-OR can be left in position for a complete abdominal procedure.
In the relaxed position, the Space-OR is malleable and can be placed along a wound edge or in the abdominal cavity. The device can be shaped around the desired organs forming an optimum retractor. The Space-OR includes a connector for wall vacuum. When vacuum is pulled, the device then solidifies, staying in the position formed by the user. The Space-OR will maintain its shape, retracting the desired organs or areas until the clamp is released.
The vacuum applied to the Space-OR must be greater than 150 mmHg for the device to become solid. Once applied, the evacuation tubing is clamped and the vacuum pump removed. The device may be maintained in place for the duration of the surgery. If desired, the user can release the clamp on the vacuum, reposition the Space-OR and re-apply the vacuum.
The provided text describes a 510(k) summary for the Advanced Surgical Concepts Space-OR Retractor, a manual surgical instrument. It is exempt from providing detailed performance testing results typically seen in AI/ML device submissions. Therefore, many of the requested details related to acceptance criteria, ground truth, and expert evaluation are not available in this document.
However, based on the information provided, here's a summary of the available "acceptance criteria" and "study" information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Maintain solid state at >150 mmHg vacuum | "The vacuum applied to the Space-OR must be greater than 150 mmHg for the device to become solid. Once applied, the evacuation tubing is clamped and the vacuum pump removed. The device may be maintained in place for the duration of the surgery." |
| Biocompatibility | "The patient-contacting materials used in the Space-OR have been subjected to and passed biocompatibility testing according to ISO-10993." |
| Function as intended in vivo (animal model) | "Animal testing has been performed showing that the Space-OR functions as intended." |
| No adverse effects/complications in clinical use | "Additionally, the Space-OR has been in commercial distribution in Europe for over nine years with no complications or adverse effects." |
2. Sample Size Used for the Test Set and Data Provenance
- Animal Testing: The document states "Animal testing has been performed," but does not specify the number of animals or the exact study design.
- Clinical Use in Europe: "in commercial distribution in Europe for over nine years." No specific "test set" size is provided; this refers to real-world usage. The data provenance is described as clinical use in Europe, which is retrospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a manual surgical instrument, not an AI/ML imaging device requiring expert ground truth for image interpretation. The "ground truth" for its performance is its physical function and clinical safety.
4. Adjudication Method for the Test Set
Not applicable. No expert review leading to adjudication is mentioned for this type of device.
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. This is not an AI/ML device, and no MRMC study information is provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The Type of Ground Truth Used
- Bench Testing: The ability to "become solid" at a specified vacuum level would have been verified through bench testing.
- Biocompatibility Testing: Performed per ISO-10993 standards.
- Functionality: Assessed in animal models.
- Safety/Effectiveness: Observed via "no complications or adverse effects" during nine years of commercial distribution in Europe.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set for this device.
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510(k) SUMMARY for ADVANCED SURGICAL CONCEPTS SPACE-OR RETRACTOR
1. SPONSOR
Advanced Surgical Concepts (ASC) Unit 4, Sunnybank Centre, Bray County Wicklow Ireland
| Contact Person: | Shane MacNally |
|---|---|
| Telephone: | 353 1 2864777 |
| Date Prepared: | October 18, 1999 |
2. DEVICE NAME
| Proprietary Name: | Space-OR Retractor |
|---|---|
| Common/Usual Name: | Retractor |
| Classification Name: | Manual Surgical Instruments for General Use |
PREDICATE DEVICES 3.
Lone Star Instruments Retractor System [exempt from 510(k)] Sklar Surgical Instruments ALM and Meyerding Retractor [exempt from 510(k)]
4. DEVICE DESCRIPTION
The Space-OR is a flexible retractor which can be formed by the user into the desired shape for retraction of organs or tissues during abdominal surgery. The Space-OR can be left in position for a complete abdominal procedure.
In the relaxed position, the Space-OR is malleable and can be placed along a wound edge or in the abdominal cavity. The device can be shaped around the desired organs forming an optimum retractor. The Space-OR includes a connector for wall vacuum. When vacuum is pulled, the device then solidifies, staying in the position formed by the user. The Space-OR will maintain its shape, retracting the desired organs or areas until the clamp is released.
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The vacuum applied to the Space-OR must be greater than 150 mmHg for the device to become solid. Once applied, the evacuation tubing is clamped and the vacuum pump removed. The device may be maintained in place for the duration of the surgery. If desired, the user can release the clamp on the vacuum, reposition the Space-OR and re-apply the vacuum.
INTENDED USE પં
The Space-OR is a flexible internal retractor intended for retraction of organs and tissues during abdominal surgery.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
The Space-OR Retractor is substantially equivalent to the Sklar Surgical Instruments Meyerding Retractor and the ALM Self Retaining Retractor, and the Lone Star Products Retractor System.
The Space-OR is identical in intended use to the Lone Star and Sklar mechanical retractors in that they are all intended to be positioned over target organs or tissues for retraction during abdominal surgery.
The technological characteristics of the Space-OR are similar to the substantially equivalent devices. They are all designed to be positioned over the target area in the abdominal cavity and function as a retractor to hold back organs and/or tissues from the operative area. Metal is used in the substantially equivalent devices whereas the proposed Space-OR is made of PVC. This difference does not adversely affect safety or effectiveness since the PVC has been subjected to and has passed biocompatibility testing. Additionally, the Space-OR has been tested in pigs and has been used clinically in Europe for several years with no adverse effects or complications.
PERFORMANCE TESTING 7.
The patient-contacting materials used in the Space-OR have been subjected to and passed biocompatibility testing according to ISO-10993. Animal testing has been performed showing that the Space-OR functions as intended. Additionally, the Space-OR has been in commercial distribution in Europe for over nine years with no complications or adverse effects.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 22 1999
Re:
Advanced Surgical Concepts c/o Ms. Mary McNamara-Cullinane, RAC Staff Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760
K993544 Trade Name: Advanced Surgical Concepts Space-OR Retractor Regulatory Class: I Product Code: FFO Dated: October 18, 1999 Received: October 19, 1999
Dear Ms. McNamara-Cullinane:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Mary McNamara-Cullinane, RAC
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Hypt. Rhodes
E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K993544
Device Name: Advanced Surgical Concepts Space-OR Retractor
Indications for Use:
The Space-OR Retractor is a flexible internal retractor intended for the retraction of organs and tissues during abdominal surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hurt Rhodes
(Division Sien-Off) Division of General Restorative Devices K993544 510(k) Number J
Prescription Use
(Per 21 CFR 801.109)
OR
10/18/99
Over-The-Counter Use
(Optional Format 1-2-96)
§ 876.4730 Manual gastroenterology-urology surgical instrument and accessories.
(a)
Identification. A manual gastroenterology-urology surgical instrument and accessories is a device designed to be used for gastroenterological and urological surgical procedures. The device may be nonpowered, hand-held, or hand-manipulated. Manual gastroenterology-urology surgical instruments include the biopsy forceps cover, biopsy tray without biopsy instruments, line clamp, nonpowered rectal probe, nonelectrical clamp, colostomy spur-crushers, locking device for intestinal clamp, needle holder, gastro-urology hook, gastro-urology probe and director, nonself-retaining retractor, laparotomy rings, nonelectrical snare, rectal specula, bladder neck spreader, self-retaining retractor, and scoop. A manual surgical instrument that is intended specifically for use as an aid in the insertion, placement, fixation, or anchoring of surgical mesh during urogynecologic procedures are classified under § 884.4910 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.